UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒ ANNUAL REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended: December
31 , 2025
or
☐ TRANSITION REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______________
to _______________
Commission file number: 001-39336
Aditxt, Inc.
(Exact name of registrant as specified in its
charter)
Delaware 82-3204328
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
2569 Wyandotte Street , Suite 101
Mountain View , CA 94043
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including
area code: (650) 870-1200
Securities registered pursuant to Section 12(b) of
the Act:
Title of each Class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.001 per share ADTX The Nasdaq Stock Market LLC
Securities registered pursuant to Section 12(g) of
the Act: None
Indicate by check mark if the registrant is a
well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not
required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐ No ☒
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted posted pursuant to Rule 405 of Regulation S-T (§
232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post
such files). Yes ☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report. ☐
If securities are registered pursuant to Section
12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in this filing reflect the correction
of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error
corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s
executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value of the voting and
non-voting common equity held by non-affiliates of the registrant on June 30, 2025, based on a closing price of $1,157.12 was approximately
$ 4,316,100 .
As of March 30, 2026, the registrant had 904,469 and 904,468 shares
of common stock, $0.001 par value per share, issued and outstanding, respectively.
DOCUMENTS INCORPORATED BY REFERENCE
None
ADITXT, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2025
TABLE OF CONTENTS
PART
I
1
Item
1
Business
1
Item
1A
Risk
Factors
13
Item
1B
Unresolved
Staff Comments
38
Item 1C
Cybersecurity
38
Item
2
Properties
39
Item
3
Legal
Proceedings
39
Item
4
Mine
Safety Disclosures
39
PART
II
40
Item
5
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
40
Item
6
[Reserved]
40
Item
7
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
41
Item
7A
Quantitative
and Qualitative Disclosures About Market Risk
55
Item
8
Financial
Statements and Supplementary Data
55
Item
9
Changes
in and Disagreements with Accountants on Accounting and Financial Disclosure
55
Item
9A
Controls
and Procedures
55
Item
9B
Other
Information
55
Item
9C
Disclosure
Regarding Foreign Jurisdictions that Prevent Inspections
56
PART
III
57
Item
10
Directors,
Executive Officers and Corporate Governance
57
Item
11
Executive
Compensation
63
Item
12
Security
Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
69
Item
13
Certain
Relationships and Related Transactions, and Director Independence
69
Item
14
Principal
Accountant Fees and Services
70
PART
IV
71
Item
15
Exhibits
and Financial Statement Schedules
71
SIGNATURES
83
i
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form
10-K contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act
of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions,
estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond
our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance
or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are
statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such
as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,”
“would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,”
“continue,” “plan,” “point to,” “project,” “predict,” “could,”
“intend,” “target,” “potential” and other similar words and expressions of the future. The matters
discussed in these forward-looking statements are subject to risks, uncertainties and other factors that could cause our actual results
to differ materially from those projected, anticipated or implied in the forward-looking statements. As a result, you should not place
undue reliance on any forward-looking statements. Except to the limited extent required by applicable law, we undertake no obligation
to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
ii
PART I
Item 1. Business.
Overview and Mission
We
believe the world needs—and deserves—a new approach to innovation that harnesses the power of large groups of stakeholders
who work together to ensure that the most promising innovations reach people who need them most.
We
were incorporated in the State of Delaware on September 28, 2017, and our headquarters are in Mountain View, California. The Company
was founded with a mission of redefining how health innovations are discovered, developed, and deployed—transforming a highly centralized
industry into a socially owned and guided ecosystem to advance human well-being. The socialization of innovation through engaging stakeholders
in every aspect of it, is key to transforming more innovations, more rapidly, and more efficiently.
At
inception, the first innovation we took on was an immune modulation technology titled ADI/Adimune with a focus on prolonging life and
enhancing life quality of patients that have undergone organ transplants. Since then, we expanded our portfolio of innovations and subsidiaries,
and we continue to evaluate a variety of promising health innovations.
ADIMUNE ™ ,
INC. Subsidiary
Formed
in January 2023, Adimune™, Inc. (“Adimune”) is focused on leading our immune modulation therapeutic programs. Adimune’s
proprietary immune modulation product, Apoptotic DNA Immunotherapy™ (ADI™), utilizes a novel approach that mimics the way
our bodies naturally induce tolerance to our own tissues. It includes two DNA molecules designed to deliver signals to induce tolerance.
ADI-100, the first product candidate based on the ADI platform, is designed to tolerize against an antigen known as glutamic acid decarboxylase
(“GAD”), which is implicated in type-1 diabetes (T1D), psoriasis, and in many autoimmune diseases of the CNS and has been
successfully tested in several preclinical models (e.g., skin grafting, psoriasis, and T1D).
All
preclinical studies for ADI-100 have been completed providing several data points supporting the potential effectiveness of ADI-100 in
restoring durable tolerance as illustrated in 10-month studies in prevention and treatment of T1D in nonclinical animal models. Preclinical
safety and toxicology studies have shown absence of drug toxicity, no antibody formation to the drug product, and a lack of persistence
in all organs evaluated except the skin (at the injection site). Furthermore, Adimune has demonstrated in three separate preclinical
studies that ADI-100 does not impair the responsiveness of the immune system to combat infection, cancer, or the tumor fighting capabilities
of checkpoint inhibitors.
Good
Manufacturing Practices (GMP) clinical-grade drug substances have been successfully manufactured by a qualified contract manufacturer.
The clinical grade drug substances are now being prepared for shipment to another contract manufacturer to be formulated into the final
drug product in preparation for stability testing and use in the clinical trials pending required regulatory submissions. Lastly, one
remaining drug product release stability assay specifically designed for ADI-100 is in the final stages of qualification to be used once
the final drug product is ready.
Preclinical
and manufacturing data, including the clinical-grade drug substance, are essential components of the complete dossier that we intend
to submit to the regulatory agencies, which evaluate the safety and quality of the final drug product to be administered in the clinical
trials. Adimune has had pre-submission meetings with the regulatory agency in Germany and has completed the additional studies requested.
For
the clinical trials that are planned in Germany, Adimune has engaged with a Contract Research Organization (CRO) to manage the process,
including site selection for clinical studies planned in psoriasis and T1D. In parallel, Adimune is working with the Mayo Clinic to prepare
the IND package for FDA submission and is awaiting a pre-IND meeting expected in the second quarter of this year to review the package
before full submission. In May 2023, Adimune entered into a clinical trial agreement with the Mayo Clinic to advance clinical studies
targeting autoimmune diseases of the central nervous system (“CNS”) with the initial focus on the rare, but debilitating,
autoimmune disease Stiff Person Syndrome (“SPS”). According to the National Organization of Rare Diseases, the exact incidence
and prevalence of SPS is unknown; however, one estimate places the incidence at approximately one in one million individuals in the general
population. Pending approval by the International Review Board and U.S. Food and Drug Administration, a human trial for SPS is expected
to get underway in 2026 with enrollment of 10-20 patients, some of whom may also have T1D. In these studies, the primary readouts for
ADI-100 will be safety and tolerability as well as clinical and immunological signals of tolerance induction.
1
Background
The
discovery of immunosuppressive (anti-rejection and monoclonal antibodies) drugs over the past 40 years has made possible life-saving
organ transplantation procedures and blocking of unwanted immune responses in autoimmune diseases. However, immune suppression leads
to significant undesirable side effects, such as increased susceptibility to life-threatening infections and cancers, because it indiscriminately
and broadly suppresses immune function throughout the body. While the use of these drugs has been justifiable because they prevent or
delay organ rejection, their use for treatment of autoimmune diseases and allergies may not be widely acceptable because of the aforementioned
side effects. Furthermore, often transplanted organs ultimately fail despite the use of immune suppression, and about 40% of transplanted
organs survive no more than five years.
Through
Aditxt, Adimune has the right to the exclusive worldwide license for commercializing ADI nucleic acid-based technology from Loma Linda
University. ADI has been designed to use a novel approach that mimics the way the body naturally induces tolerance to our own tissues
(“therapeutically induced immune tolerance”). While immune suppression requires continuous administration to prevent rejection
of a transplanted organ, induction of tolerance has the potential to retrain the immune system to accept the organ for longer periods
of time. ADI may potentially allow patients to live with transplanted organs with significantly reduced need for immune suppression.
ADI is a technology platform which we believe can be engineered to address a wide variety of indications.
Advantages
ADI™
is a nucleic acid-based technology ( e.g. , DNA-based), which we believe selectively suppresses only those immune cells involved
in attacking (in autoimmune diseases) or rejecting self (in transplanted tissues and organs). It does so by tapping into the body’s
natural process of cell turnover (i.e., apoptosis) to retrain the immune system to stop unwanted attacks on self or transplanted tissues.
Apoptosis is a natural process used by the body to clear dying cells and to allow recognition and tolerance to self-tissues. ADI triggers
this process by enabling the cells of the immune system to recognize the targeted tissues as “self.” Conceptually, it is
designed to retrain the immune system to accept the tissues, similar to how natural apoptosis reminds our immune system to be tolerant
to our own “self” tissues.
While
various groups have promoted tolerance through cell therapies and ex vivo manipulation of patient cells (i.e., conducted
outside the body), to our knowledge, we will be unique in our approach of using in-body induction of apoptosis to promote tolerance to
specific tissues. In addition, ADI treatment itself will not require additional hospitalization but only an injection of minute
amounts of the therapeutic drug into the skin.
Moreover,
preclinical studies have demonstrated that ADI treatment significantly and substantially prolongs graft survival, in addition to successfully
“reversing” other established immune-mediated inflammatory processes.
License Agreement
with Loma Linda University (“LLU”)
On
March 15, 2018, we entered into a License Agreement with LLU, which was subsequently amended on July 1, 2020. Pursuant to the LLU License
Agreement, we obtained the exclusive royalty-bearing worldwide license to all intellectual property, including patents, technical information,
trade secrets, proprietary rights, technology, know-how, data, formulas, drawings, and specifications, owned or controlled by LLU and/or
any of its affiliates (the “LLU Patent and Technology Rights”) and related to therapy for immune-mediated inflammatory diseases
(the ADI™ technology). In consideration of the LLU License Agreement, we issued 1 share of common stock to LLU.
2
PEARSANTA, INC.
Subsidiary
The
best approach for addressing cancer may be its early detection. Pearsanta is pioneering the development of molecular tests based on the
mitochondrial DNA (mtDNA) to develop tests for early detection of cancer. Though further technical development and clinical validation
is required to determine efficacy in multiple diseases and disease states, our management believes that the unique structural and functional
characteristics of mtDNA, and more specifically mutated mtDNA, render it a biological system suitable for biomarker identification, early
disease detection, monitoring, risk assessment, and therapeutic targeting.
Pearsanta
acquired the assets of MDNA Life Sciences, Inc. on January 4, 2024. Through the acquisition of these assets, and in particular the Mitomic ®
Technology platform, patents, and intellectual property, our management believes that Pearsanta is well positioned for research and discovery
of mtDNA-based biomarkers, and though untested and requiring clinical validation, the development and commercial application of mtDNA-based
biomarkers for a wide spectrum of human diseases.
Pearsanta
is continuing to leverage this technology to discover mtDNA-based biomarkers. Though Pearsanta has no commercially available FDA or foreign
regulatory approved products, Pearsanta has two product candidates in development and hopes to enter the cancer screening market with
these two product candidates, and if proven successful continue to discover additional mtDNA-based biomarkers and develop a pipeline
of disease screening and diagnostics tests. The current in-development products include a potential product for prostate cancer diagnosis
and a potential product for the detection of endometriosis. Pearsanta has also discovered mtDNA-based biomarkers, which it believes are
associated with ovarian cancer and lung cancer; and Pearsanta intends to pursue the biomarker identification phase of development for
pancreatic, liver, breast, stomach, esophageal, and colorectal cancers.
Licensed Technologies
– AditxtScore TM
We
issued Pearsanta an exclusive worldwide sub-license (the “Exclusive Worldwide Sublicense Agreement”) for commercializing
the AditxtScore™ technology which provides a personalized comprehensive profile of the immune system. AditxtScore is intended to
detect individual immune responses to viruses, bacteria, peptides, drugs, supplements, bone marrow and solid organ transplants, and cancer.
It has broad applicability to many other agents of clinical interest impacting the immune system, including those not yet identified
such as emerging infectious agents. On September 23, 2025, the Company and Pearsanta entered in a Mutual Termination Agreement (the “Exclusive
Worldwide Sublicense Termination Agreement”) to terminate the Exclusive Worldwide Sublicense Agreement. As provided in the Exclusive
Worldwide Sublicense Termination Agreement, the Exclusive Worldwide Sublicense Agreement has been terminated in its entirety and all
rights and obligations of the parties under the Exclusive Worldwide Sublicense Agreement have ceased. A non-exclusive licensing agreement
has been granted by Aditxt to Pearsanta as of December 30, 2025 for the use of the technology for evaluating levels of antibodies and
neutralizing antibodies to SARS-CoV-2, which are currently available in use by the CLIA/CAP facility in Richmond, VA.
Advantages
The
advantages of the AditxtScore technology include the following:
●
greater sensitivity/specificity.
●
20-fold higher dynamic
range, greatly reducing signal to noise compared to conventional assays.
●
ability to customize assays
and multiplex a large number of analytes with speed and efficiency.
●
ability to test for cellular
immune responses (i.e., T and B cells and cytokines).
●
proprietary reporting algorithm.
3
License Agreement
with Leland Stanford Junior University (“Stanford”)
On
February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford with
regard to a patent concerning a method for detection and measurement of specific cellular responses. Pursuant to the February 2020 License
Agreement, we received an exclusive worldwide license to Stanford’s patent with regard to use, import, offer, and sale of Licensed
Products (as defined in the agreement). The license to the patented FlowSpot technology is exclusive, including the right to sublicense,
beginning on the effective date of the agreement, and ending when the patent expires. Under the exclusivity agreement, we acknowledged
that Stanford had already granted a non-exclusive license in the Nonexclusive Field of Use, under the Licensed Patents in the Licensed
Field of Use in the Licensed Territory (as those terms are defined in the “February 2020 License Agreement”). However, Stanford
agreed not to grant further licenses under the Licensed Patents in the Licensed Field of Use in the Licensed Territory. On December 29,
2021, we entered into an amendment to the February 2020 License Agreement which extended our exclusive right to license the technology
and securing worldwide exclusivity in all fields of use of the licensed technology.
AditxtScore
and FlowSpot have been designed to enable individuals and their healthcare providers to understand, manage and monitor their immune profiles
and to stay informed about attacks on or by their immune system. We believe these platforms can also assist the medical community and
individuals in anticipating the immune system’s potential response to viruses, bacteria, allergens, and foreign tissues such as
transplanted organs. These technologies may be able to serve as tools allowing for more time to respond appropriately. Their advantages
include the ability to provide simple, rapid, accurate, high throughput assays that can be multiplexed to determine immune status with
respect to several factors simultaneously, in approximately 3-16 hours. In addition, they can determine and differentiate between distinct
types of cellular and humoral immune responses (e.g., T and B cells and other cell types). The FlowSpot technology can also provide simultaneous
monitoring of cell activation and levels of cytokine release (i.e., cytokine storms).
In
collaboration with its partners, the platforms underlying AditxtScore and FlowSpot are being further evaluated for evaluating the immune
status of individuals including those with hypersensitivity to certain antigens (e.g., patients with autoimmunity). These tests may become
tools that can monitor dynamic changes after administration of immunotherapies designed to tolerize to these target antigens.
Technologies
– Mitomic ® Technology Platform
In
January 2024, Pearsanta acquired the assets comprising our Mitomic ® Technology platform from MDNA Life Sciences Inc. This
platform seeks to harness the unique properties of mitochondrial DNA (“mtDNA”) to detect disease through non-invasive, blood-based
liquid biopsies. Though further technical development and clinical validation is required to determine efficacy in multiple diseases
and disease states, our management believes that the unique structural and functional characteristics of mtDNA, and more specifically
mutated mtDNA, make mtDNA a biological system suitable for biomarker identification, early disease detection, monitoring, risk assessment,
and therapeutic targeting.
Pearsanta
plans to license distribution rights through various agreements with U.S.-based and international business partners to commercialize
our Mitomic ® Technology, should Mitomic ® tests be successfully developed and successfully approved by the
FDA, or a foreign regulator or other relevant regulatory agency. We believe our biomarker portfolio covers many high-clinical need cancers,
with potential applications outside oncology.
Pearsanta
leases a state-of-the-art facility located in Richmond VA, that is a high-complexity, CLIA-certified, CAP-accredited and NYS CLEP-approved
laboratory equipped to accommodate rapid development and rollout of innovative laboratory tests for the clinical market. Our laboratory
facility is optimized for contamination prevention including dedicated workspaces for key functions; advanced molecular biology capabilities
including digital PCR, real-time PCR, automated electrophoresis with scale-up capacity and redundancy; and automated and semi-automated
(robotic) processes for DNA/RNA isolation and liquid handling to achieve efficient and standardized workflows.
4
Our Mitomic ®
Products and Product Candidates
The
Mitomic ® Technology targets mutations in mtDNA to detect disease. Every human cell is home to multiple
copies of mtDNA, some of which become mutated beyond repair when cells are stressed by diseases such as cancer. Though further technical
development and clinical validation is required to determine utility, Mitomic ® tests are being designed to detect this
mutated DNA, which can accumulate from the very early stages of a disease. If the development of Mitomic ® tests is successful
and if Mitomic ® tests can achieve their still unproven objective of early disease detection, our Mitomic ®
Technology presents an opportunity to detect disease before it presents clinically.
The
Mitomic ® Technology platform is designed to identify biomarker targets, develop robust assays, discover new biomarkers,
and develop new products. The biomarker identification program is based on the identification of a new class of molecules generated through
a process associated with mitochondria. The Mitomic ® Technology platform has already discovered biomarkers which are believed
to be associated with cancer and has generated an “in-silico” database, which is an experiment that generates thousands of
potential biomarkers, developed through computer software and simulation.
To
date, the Mitomic ® Technology biomarker discoveries have identified numerous biomarker targets from the in-silico database,
and we plan to use these biomarker targets in our various assay development programs.
Mitomic ®
Prostate Test (MPT™) is currently in development and is being designed as a blood-based assay that quantifies the level
of the 3.4kb mtDNA deletion. Published analytical data for the 3.4kb mtDNA deletion associated with prostate cancer, suggests the 3.4kb
mtDNA deletion may be able to identify clinically significant prostate cancer for men in the prostate-specific antigen (PSA) grey zone
(PSA < 10ng/ml) and if proven through ongoing clinical study, the 3.4kb mtDNA deletion may be able to aid in the decision to biopsy.
Some of the significant clinical challenges that have not been met for prostate cancer are that up to 50% of men will be ‘over’
diagnosed with cancer that never harms them and the risks associated with treatment of low-grade cancers (≤ Gleason 6) appear
to outweigh the benefits –e.g. urinary incontinence, erectile dysfunction. 1 NIH National Cancer Institute
reports this number is even higher at ~ 75% based on 5-year survival rates. Seer database (https://seer.cancer.gov/statfacts/html/prost.html).
Mitomic ®
Prostate Test (MPT™) is in development and is being designed with the following objectives:
●
Simple – The test
is expected to be completed using a patient’s blood sample and is not expected to require an algorithm.
●
Provide New Information
– If ongoing clinical studies support the published analytical data for the 3.4kb mtDNA deletion, healthcare providers will
be provided with new information related to clinically significant prostate cancer – independent of PSA, age, and family history.
Mitomic
Endometriosis Test (MET™) is currently in development and is being designed as a blood-based assay that quantifies the
level of one or more mtDNA deletions which published analytical data suggest are associated with endometriosis – a condition affecting
approximately 1 in 10 women according to Endometriosis World and the World Health Organization. The MET is intended for use in females
of child-bearing age who present symptoms of endometriosis to determine whether medical or surgical intervention is warranted.
Endometriosis
occurs when the tissue of the uterus (endometrium) grows in areas where it does not belong, most often on the ovaries, fallopian tubes,
outer surface of the uterus, and tissues holding the uterus, but can be found almost anywhere in the body. Endometriosis is challenging
to identify, and on average takes ten years to diagnose, and when patients are finally diagnosed, greater than 90% have moderate to severe
symptoms.
Technologies – Adductomics Technology
On
March 21, 2025, Pearsanta acquired certain patents related to the detection and analysis of DNA adducts. DNA adducts are chemically
modified nucleotides that result from exposure to carcinogens and other damaging agents, serving as early indicators of genomic instability
and increased cancer risk. The technology includes proprietary mass-tag enhancements designed to improve the sensitivity and specificity
of DNA adduct detection across a full genomic landscape.
5
Pearsanta
intends to develop this platform to enable a comprehensive, panoramic assessment of DNA adducts using urine, blood, or solid tissue samples.
This approach aims to provide actionable insights into DNA damage before mutations occur, offering the potential to identify environmental
or biological factors that contribute to cancer risk. The development roadmap includes further validation of the technology and the creation
of commercially available diagnostic kits. While still in the early stages, Pearsanta anticipates that additional development over the
next two to three years will advance this platform toward clinical and commercial applications.
ADIVIR™
INC. Subsidiary
Formed
in April 2023, Adivir™, Inc. (“Adivir”) is a wholly owned subsidiary of Aditxt, Inc., dedicated to advancing the clinical
and commercial development of innovative products intended to address significant unmet needs in infectious disease and population health.
Adivir
is focused on building a portfolio of antiviral and other antimicrobial solutions designed to target life-threatening viral infections
and emerging pathogens. Its strategic objective is to identify, develop, and commercialize therapeutic candidates that have the potential
to improve treatment access and outcomes in areas where existing options are limited or inadequate.
We
believe the global healthcare landscape underscores the critical importance of strengthening antiviral preparedness and accelerating
development of both novel and repurposed therapeutic solutions. Through Adivir, the Company seeks to contribute to addressing the ongoing
and evolving challenges posed by infectious diseases worldwide.
ADIFEM, INC. Subsidiary
Adifem,
Inc. (“Adifem”), f/k/a Adicure, Inc., was formed in April of 2024 connection with Aditxt’s planned strategic expansion
into women’s health through its proposed acquisition of Evofem Biosciences. Adifem is a wholly owned subsidiary of the Company dedicated
to advancing innovative solutions that address critical unmet needs in women’s health.
Although we are no longer pursuing the acquisition of Evofem Biosciences,
our commitment to women’s health reflects a broader strategic objective to invest in therapeutic areas where there are significant
unmet medical need and opportunity for meaningful patient impact. We believe that empowering women with innovative, science-driven solutions
remains an important and timely priority in global healthcare.
Evofem Merger Agreement
and Termination
On
December 11, 2023 (the “Execution Date”), Aditxt, Inc., a Delaware corporation (the “Company”) entered into an
Agreement and Plan of Merger (the “Merger Agreement”) with Adifem, a Delaware corporation and wholly owned subsidiary of
the Company (“Merger Sub”) and Evofem Biosciences, Inc., a Delaware corporation (“Evofem”), pursuant to which,
Merger Sub will be merged into and with Evofem (the “Merger”), with Evofem surviving the Merger as a wholly owned subsidiary
of the Company.
Subject
to the terms and conditions set forth in the Merger Agreement, at the effective time of the Merger (the “Effective Time”),
(i) all issued and outstanding shares of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”),
other than any shares of Evofem Common Stock held by the Company or Merger Sub immediately prior to the Effective Time, will be converted
into the right to receive an aggregate of 8 shares of the Company’s common stock, par value $0.001 per share; and
(ii) all issued and outstanding shares of Series E-1 Preferred Stock, par value $0.0001 of Evofem (the “Evofem Unconverted
Preferred Stock”), other than any shares of Evofem Unconverted Preferred Stock held by the Company or Merger Sub immediately prior
to the Effective Time, will be converted into the right to receive an aggregate of 2,327 shares of Series A-1 Convertible Preferred
Stock, par value $0.001 of the Company (the “Company Preferred Stock”), having such rights, powers, and preferences
set forth in the form of Certificate of Designation of Series A-1 Convertible Preferred Stock.
6
On
January 8, 2024, the Company, Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”),
and Evofem Biosciences, Inc., a Delaware corporation (“Evofem”) entered into the First Amendment (the “First Amendment
to Merger Agreement”), to the Agreement and Plan of Merger (the “Merger Agreement”) pursuant to which the parties agreed
to extend the date by which the joint proxy statement would be filed with the SEC until February 14, 2024.
On
January 30, 2024, the Company, Adicure and Evofem entered into the Second Amendment to the Merger Agreement (the “Second Amendment
to Merger Agreement”) to amend (i) the date of the Parent Loan (as defined in the Merger Agreement) to Evofem to be February 29,
2024, (ii) to change the date by which Evofem may terminate the Merger Agreement for failure to receive the Parent Loan to be February
29, 2024, and (iii) to change the filing date for the Joint Proxy Statement (as defined in the Merger Agreement) to April 1, 2024.
On
February 29, 2024, the Company, Adicure and Evofem entered into the Third Amendment to the Merger Agreement (the “Third Amendment
to Merger Agreement”) in order to (i) make certain conforming changes to the Merger Agreement regarding the Notes, (ii) extend
the date by which the Company and Evofem will file the joint proxy statement until April 30, 2024, and (iii) remove the requirement that
the Company make the Parent Loan (as defined in the Merger Agreement) by February 29, 2024 and replace it with the requirement that the
Company make an equity investment into Evofem consisting of (a) a purchase of 2,000 shares of Evofem Series F-1 Preferred Stock
for an aggregate purchase price of $2.0 million on or prior to April 1, 2024, and (b) a purchase of 1,500 shares of Evofem
Series F-1 Preferred Stock for an aggregate purchase price of $1.5 million on or prior to April 30, 2024.
On
April 26, 2024, the Company received notice from Evofem (the “Termination Notice”) that Evofem was exercising its right to
terminate the Merger Agreement as a result of the Company’s failure to provide the Initial Parent Equity Investment (as defined
in the Merger Agreement, as amended).
On
May 2, 2024, the Company, Adifem, Inc. f/k/a Adicure, Inc. and Evofem Biosciences, Inc. (“Evofem”) entered into the Reinstatement
and Fourth Amendment to the Merger Agreement (the “Fourth Amendment”) in order to waive and amend, among other things, the
several provisions listed below.
Amendments
to Article VI: Covenants and Agreement
Article
VI of the Merger Agreement is amended to:
●
reinstate the Merger Agreement,
as amended by the Fourth Amendment, as if never terminated;
●
reflect the Company’s
payment to Evofem, in the amount of $1,000,000 (the “Initial Payment”), via wire initiated by May 2, 2024;
●
delete Section 6.3, which
effectively eliminates the “no shop” provision, and the several defined terms used therein;
●
add a new defined term
“Company Change of Recommendation;” and
●
revise section 6.10 of
the Merger Agreement such that, after the Initial Payment, and upon the closing of each subsequent capital raise by the Company (each
a “Parent Subsequent Capital Raise”), the Company shall purchase that number of shares of Evofem’s Series F-1 Preferred
Stock, par value $0.0001 per share (the “Series F-1 Preferred Stock”), equal to forty percent (40%) of the gross
proceeds of such Parent Subsequent Capital Raise divided by 1,000, up to a maximum aggregate amount of $2,500,000 or 2,500 shares
of Series F-1 Preferred Stock. A maximum of $1,500,000 shall be raised prior to September 17, 2024, and $1,000,000 prior
to July 1, 2024 (the “Parent Capital Raise”).
7
Amendments
to Article VIII: Termination
Article
VIII of the Merger Agreement is amended to:
●
extend the date after which
either party may terminate from May 8, 2024 to July 15, 2024;
●
revise Section 8.1(d) in
its entirety to allow Company to terminate at any time after there has been a Company Change of Recommendation, provided that Aditxt
must receive ten day written notice and have the opportunity to negotiate a competing offer in good faith; and
●
amend and restate Section
8.1(f) in its entirety, granting the Company the right to terminate the agreement if (a) the full $1,000,000 Initial Payment
required by the Fourth Amendment has not been paid in full by May 3, 2024 (b) $1,500,000 of the Parent Capital Raise Amount
has not been paid to the Company by June 17, 2024, (c) $1,000,000 of the Parent Capital Raise Amount has not been paid to the
Company by July 1, 2024, or (d) Aditxt does not pay any portion of the Parent Equity Investment within five calendar days after each
closing of a Parent Subsequent Capital Raise.
Amended and Restated Merger Agreement
On
July 12, 2024 (the “A&R Execution Date”), the Company entered into an Amended and Restated Agreement and Plan of Merger
(the “Merger Agreement”) with Adifem, Inc. f/k/a Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the
Company (“Merger Sub”) and Evofem, pursuant to which, Merger Sub will be merged into and with Evofem (the “Merger”),
with Evofem surviving the Merger as a wholly owned subsidiary of the Company. The Merger Agreement amended and restated that certain
Agreement and Plan of Merger dated as of December 11, 2023, by and among the Company, Merger Sub and Evofem (as amended, the “Original
Agreement”).
Effect on Capital Stock
Subject
to the terms and conditions set forth in the Merger Agreement, at the effective time of the Merger (the “Effective Time”),
(i) all issued and outstanding shares of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”),
other than any shares of Evofem Common Stock either held by the Company or Merger Sub immediately prior to the Effective Time or which
are Dissenting Shares (as hereinafter defined), will be converted into the right to receive an aggregate of $1,800,000; and (ii) each
issued and outstanding share of Series E-1 Preferred Stock, par value $0.0001 of Evofem (the “Evofem Unconverted Preferred
Stock”), other than any shares of Evofem Unconverted Preferred Stock either held by the Company or Merger Sub immediately prior
to the Effective Time or which are Dissenting Shares, will be converted into the right to receive one (1) share of Series A-2 Preferred
Stock, par value $0.001 of the Company (the “Company Preferred Stock”), having such rights, powers, and preferences
set forth in the form of Certificate of Designation of Series A-2 Preferred Stock, the form of which is attached as Exhibit C to the
Merger Agreement.
Any
Evofem capital stock outstanding immediately prior to the Effective Time and held by an Evofem shareholder who has not voted in favor
of or consented to the adoption of the Merger Agreement and who is entitled to demand and has properly demanded appraisal for such Company
Capital Stock in accordance with the Delaware General Corporation Law (“DGCL”), and who, as of the Effective Time, has not
effectively withdrawn or lost such appraisal rights (such Evofem capital Stock, “Dissenting Shares”) shall not be converted
into or be exchangeable for the right to receive a portion of the Merger Consideration and, instead, shall be entitled to only those
rights as set forth in the DGCL. If, after the Effective Time, any such holder fails to perfect or withdraws or loses his, her or its
right to appraisal under the DGCL, with respect to any Dissenting Shares, upon surrender of the certificate(s) representing such Dissenting
Shares, such Dissenting Shares shall thereupon be treated as if they had been converted as of the Effective Time into the right to receive
the portion of the merger consideration, if any, to which such Evofem capital stock is entitled pursuant to the Merger Agreement, without
interest.
As
a closing condition for the Company, there shall be no more than 4,141,434 Dissenting Shares that are Evofem Common Stock or 98 Dissenting
Shares that are Evofem Preferred Stock.
8
Treatment
of Evofem Options and Employee Stock Purchase Plan
At
the Effective Time, each option outstanding under the Evofem 2014 Equity Incentive Plan, the Evofem 2018 Inducement Equity Incentive
Plan and the Evofem 2019 Employee Stock Purchase Plan (collectively, the “Evofem Option Plans”), whether or not vested, will
be canceled without the right to receive any consideration, and the board of directors of Evofem shall take such action such that the
Evofem Option Plans are cancelled as of the Effective Time.
As
soon as practicable following the A&R Execution Date, Evofem will take all action that may be reasonably necessary to provide that:
(i) no new offering period will commence under the Evofem 2019 Employee Stock Purchase Plan (the “Evofem ESPP”); (ii) participants
in the Evofem ESPP as of the A&R Execution Date shall not be permitted to increase their payroll deductions or make separate non-payroll
contributions to the Evofem ESPP; and (iii) no new participants may commence participation in the Evofem ESPP following the A&R Execution
Date. Prior to the Effective Time, Evofem will take all action that may be reasonably necessary to: (A) cause any offering period or
purchase period that otherwise be in progress at the Effective Time to be the final offering period under the Evofem ESPP and to be terminated
no later than five business days prior to the anticipated closing date (the “Final Exercise Date”); (B) make any pro-rata
adjustments that may be necessary to reflect the shortened offering period or purchase period; (C) cause each participant’s then-outstanding
share purchase right under the Evofem ESPP to be exercised as of the Final Exercise Date; and (D) terminate the Evofem ESPP, as of and
contingent upon, the Effective Time.
Representations and Warranties
The
parties to the Merger Agreement have agreed to customary representations and warranties for transactions of this type.
Covenants
The
Merger Agreement contains various customary covenants, including but not limited to, covenants with respect to the conduct of Evofem’s
business prior to the Effective Time.
Closing Conditions
Mutual
The
respective obligations of each of the Company, Merger Sub and Evofem to consummate the closing of the Merger (the “Closing”)
are subject to the satisfaction or waiver, at or prior to the closing of certain conditions, including but not limited to, the following:
(i)
approval by the Evofem
shareholders;
(ii)
the entry into a voting
agreement by the Company and certain members of Evofem management;
(iii)
all preferred stock of
Evofem other than the Evofem Unconverted Preferred Stock shall have been converted to Evofem Common Stock;
9
(iv)
Evofem shall have received
agreements (the “Evofem Warrant Holder Agreements”) from all holders of Evofem warrants which provide:
(a)
waivers with respect to
any fundamental transaction, change in control or other similar rights that such warrant holder may have under any such Evofem warrants,
and (b) an agreement to such Evofem warrants to exchange such warrants for not more than an aggregate (for all holders of Evofem
warrants) of 930,336 shares of Company Preferred Stock;
(v)
Evofem shall have cashed
out any other holder of Evofem warrants who has not provided an Evofem Warrant Holder Agreement; and
(vi)
Evofem shall have obtained
waivers from the holders of the convertible notes of Evofem (the “Evofem Convertible Notes”) with respect to any fundamental
transaction rights that such holder may have under the Evofem Convertible Notes, including any right to vote, consent, or otherwise
approve or veto any of the transactions contemplated under the Merger Agreement.
(vii)
The Company shall have
received sufficient financing to satisfy its payment obligations under the Merger Agreement.
(viii)
The requisite stockholder
approval shall have been obtained by the Company at a Special Meeting of its stockholders to approve the Parent Stock Issuance (as
defined in the Merger Agreement) pursuant to the requirements of NASDAQ.
The Company and Merger Sub
The
obligations of the Company and Merger Sub to consummate the Closing are subject to the satisfaction or waiver, at or prior to the Closing
of certain conditions, including but not limited to, the following:
(i)
the Company shall have
obtained agreements from the holders of Evofem Convertible Notes and purchase rights they hold to exchange such Convertible Notes
and purchase rights for not more than an aggregate (for all holders of Evofem Convertible Notes) of 353 shares of Company
Preferred Stock;
(ii)
the Company shall have
received waivers from the holders of certain of the Company’s securities which contain prohibitions on variable rate transactions;
and
(iii)
the Company, Merger Sub
and Evofem shall work together between the A&R Execution Date and the Effective Time to determine the tax treatment of the Merger
and the other transactions contemplated by the Merger Agreement.
Evofem
The
obligations of Evofem to consummate the Closing are subject to the satisfaction or waiver, at or prior to the Closing of certain conditions,
including but not limited to, the following:
(i)
The Company shall be in
compliance with the stockholders’ equity requirement in Nasdaq Listing Rule 5550(b)(1) and shall meet all other applicable
criteria for continued listing.
10
Termination
The
Merger Agreement may be terminated at any time prior to the consummation of the Closing by mutual written consent of the Company and
Evofem. Either the Company or Evofem may also terminate the Merger Agreement if (i) the Merger shall not have been consummated on or
before 5:00 p.m. Eastern Time on September 30, 2024; (ii) if any judgment, law or order prohibiting the Merger or the Transactions has
become final and non-appealable; (iii) the required vote of Evofem stockholders was not obtained; or (iv) in the event of any Terminable
Breach (as defined in the Merger Agreement). The Company may terminate the Merger Agreement if (i) prior to approval by the required
vote of Evofem’s shareholders if the Evofem board of directors shall have effected a Company Change in Recommendation (as defined
in the Merger Agreement); or (ii) in the event that the Company determines, in its reasonable discretion, that the acquisition of Evofem
could result in a material adverse amount of cancellation of indebtedness income to the Company. Evofem may terminate the Merger Agreement
if (i) at any time after there has been a Company Change of Recommendation; provided, that Evofem has provided the Company ten (10) calendar
days’ prior written notice thereof and has negotiated in good faith with the Company to provide a competing offer; (ii) the Company’s
common stock is no longer listed for trading on Nasdaq; or (iii) any of: (A) the Initial Parent Equity Investment has not been made by
the Initial Parent Equity Investment Date, (B) the Second Parent Equity Investment has not been made by the Second Parent Equity Investment
Date, (C) the Third Parent Equity Investment has not been made by the Third Parent Equity Investment Date or (D) the Fourth Parent Equity
Investment has not been made by the Fourth Parent Equity Investment Date (as all of such terms are defined in the Merger Agreement).
Effect of Termination
If
the Merger Agreement is terminated, the Merger Agreement will become void, and there will be no liability under the Merger Agreement
on the part of any party thereto.
Amendments to Evofem Amended and Restated
Merger Agreement
On
August 16, 2024, the Company, Merger Sub and Evofem entered into Amendment No. 1 to the Amended and Restated Merger Agreement (“Amendment
No. 1”), pursuant to which the date by which the Company is to make the Third Parent Equity Investment (as defined under the Amended
and Restated Merger Agreement) was amended to the earlier of September 6, 2024 or five (5) business days of the closing of a public offering
by Parent resulting in aggregate net proceeds to Parent of no less than $20,000,000. Except as set forth herein, the terms and conditions
of the Amended and Restated Merger Agreement have not been modified.
On
September 6, 2024, the Company, Merger Sub and Evofem entered into Amendment No. 2 to the Amended and Restated Merger Agreement (“Amendment
No. 2”), pursuant to which the date by which the Company shall make the Third Parent Equity Investment was amended from September
6, 2024 to September 30, 2024 and adjust the amount of such investment from $2 million to $1.5 million, and to extend the date by which
Aditxt shall make the Fourth Parent Equity Investment (as defined under the Amended and Restated Merger Agreement) was amended from September
30, 2024 to October 31, 2024 and adjust the amount of such investment from $1 million to $1.5 million.
Third Evofem Amendment & Parent Equity
Investment
On
October 2, 2024, the Company, Merger Sub and Evofem entered into Amendment No. 3 to the Amended and Restated Merger Agreement in order
to extend the date by which the Company shall make the Third Parent Equity Investment to October 2, 2024, reduce the amount of the Third
Parent Equity Investment from $1.5 million to $720,000, and increase the amount of the Fourth Parent Equity Investment from $1.5 million
to $2.28 million.
On
October 2, 2024, the Company completed the purchase of 460 shares of Evofem F-1 Preferred Stock for an aggregate purchase price of $460,000.
11
Evofem Parent Equity Investment
On
October 28, 2024, the Company entered into a Securities Purchase Agreement (the “Series F-1 Securities Purchase Agreement”)
with Evofem, pursuant to which the Company purchased the Fourth Parent Equity Investment of 2,280 shares of Evofem Series F-1 Convertible
Preferred Stock for an aggregate purchase price of $2,280,000.
Fifth Amendment to Amended
and Restated Merger Agreement
On
March 23, 2025, the Company, Adicure, Inc., and Evofem entered into Amendment No. 5 to the Amended and Restated Merger Agreement (“Amendment
No. 5”), pursuant to which, the parties agreed that (i) Evofem shall use commercially reasonable efforts to hold the Company Shareholders
Meeting (as defined under the A&R Merger Agreement) no later than September 26, 2025, (ii) the Company shall invest an additional
$1,500,000 in Evofem no later than April 7, 2025 in exchange for additional shares of F-1 Preferred Stock and/or, at the Company’s
option, senior subordinated notes of Evofem, and (iii) the End Date shall be extended to September 30, 2025.
Sixth Amendment to Amended
and Restated Merger Agreement
On
August 26, 2025, the Company, Adicure, Inc., and Evofem entered into Amendment No. 6 to the Amended and Restated Merger Agreement(“Amendment
No. 6”), in order to (i) amend Sections 1.5 and 3.1(b)(ii) to update the definition of “Unconverted Company Preferred Stock
“to include Series G-1 Preferred Stock of Evofem; (ii) amend Section 1.6 to update the definition of “Company Shareholder
Approval “to include (a) the outstanding shares of Evofem common stock (including all Evofem preferred stock on the basis and to
the extent it is permitted to so vote) entitled to vote thereon, and (b) each series of the unconverted Evofem preferred stock; (iii)
amend Section 6.23 to clarify that Evofem will assist in obtaining Exchange Agreements (as defined in the Amended and Restated Merger
Agreement) to exchange Evofem convertible notes and purchase rights for an aggregate of not more than 89,021 shares of the Company’s
preferred stock from the applicable Evofem shareholders; (iv) amend Section 7.2(j) to change the number of dissenting shares to no more
than 741,603 shares of common stock or 202 shares of preferred stock; (v) add a new Section 7.2(k) to require waivers from each holder
of Evofem’s Series E-1 Convertible Preferred Stock, with respect to the last sentence of Section 2, the entirety of Section 6,
any price adjustment provisions that may be triggered under Section 8(a)(ii), Section 12(c) and Section 12(d) of the Evofem Series E-1
Certificate of Designations; and (vi)to replace in its entirety, the Certificate of Designation included as Exhibit C to the Amended
and Restated Merger Agreement.
Evofem Termination
On
October 20, 2025, Aditxt received from Evofem a notice of termination of the parties’ Merger Agreement. In the notice, Evofem cites
Section 8.1(b)(ii) (the end date having passed) and Section 8.1(b)(iv) (failure to obtain shareholder approval at the October 20, 2025
special meeting) as the basis for termination, effective October 20, 2025. No termination fee or other early-termination penalty is payable
by Aditxt in connection with Evofem’s termination pursuant to Sections 8.1(b)(ii) and 8.1(b)(iv). The Company retains its holdings
of Evofem F-1 Preferred Stock, convertible notes, and Evofem Warrants.
Employees
We
employ twenty-six (26) full-time employees as of December 31, 2025. We consider the relations with our employees to be good
12
Item 1A. Risk Factors.
You should carefully
consider the risks described below, as well as general economic and business risks and the other information in this Annual Report on
Form 10-K. The occurrence of any of the events or circumstances described below or other adverse events could have a material adverse
effect on our business, results of operations and financial condition and could cause the trading price of our common stock to decline.
Additional risks or uncertainties not presently known to us or that we currently deem immaterial may also harm our business.
RISK FACTOR SUMMARY
Our business is subject to
numerous risks and uncertainties, including those highlighted in Section 1A titled “Risk Factors,” that represent challenges
that we face in connection with the successful implementation of our strategy. The occurrence of one or more of the events or circumstances
described in the section titled “Risk Factors,” alone or in combination with other events or circumstances, may have an adverse
effect on our business, cash flows, financial condition and results of operations. Such risks include, but are not limited to:
●
our financial situation creates doubt
whether we will continue as a going concern;
●
our ability
to remain compliant with the requirements for continued listing on The Nasdaq Capital Market
●
we have generated no significant
revenue from commercial sales to date, and our future profitability is uncertain;
●
if we fail to obtain the
capital necessary to fund our operations, we will be unable to continue or complete our product development, and you will likely
lose your entire investment;
●
we may need to raise additional
funding, which may not be available on acceptable terms, or at all;
●
even if we can raise additional
funding, we may be required to do so on terms that are dilutive to you;
●
the regulatory approval
process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our future
product candidates, if any;
●
we may encounter substantial
delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety
and efficacy to the satisfaction of applicable regulatory authorities;
●
if our future pre-clinical
development and future clinical Phase I/II studies are unsuccessful, we may be unable to obtain regulatory approval of, or commercialize,
our product candidates on a timely basis or at all;
●
even if we receive regulatory
approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we
generate from their sales, if any, may be limited;
●
adverse events involving
our products may lead the FDA or applicable foreign regulatory agency to delay or deny clearance for our products or result in product
recalls that could harm our reputation, business and financial results;
●
certain technologies are
subject to licenses from LLU and Stanford (as defined below), each of which are revocable in certain circumstances, including in
the event we do not achieve certain payments and milestone deadlines. Without these licenses, we may not be able to continue to develop
our product candidates;
●
if we were to lose our
CLIA certification or state laboratory licenses, whether as a result of a revocation, suspension or limitation, we would no longer
be able to offer our assays (including our AditxtScore™ platform), which would limit our revenues and harm our business. If
we were to lose, or fail to obtain, a license in any other state where we are required to hold a license, we would not be able to
test specimens from those states;
●
our results of operations
will be affected by the level of royalty and milestone payments that we are required to pay to third parties;
●
we face substantial competition,
which may result in others discovering, developing or commercializing products before or more successfully than we do;
●
our technologies and products
under development, and our business, may fail if we are not able to successfully commercialize them and ultimately generate significant
revenues as a result;
●
customers may not adopt
our products quickly, or at all;
13
●
the failure to obtain or
maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete effectively;
●
some of our intellectual
property may be subject to “march-in” rights by the U.S. federal government;
●
we do not expect to pay
dividends in the foreseeable future;
●
we have issued a significant
number of shares of convertible preferred stock and warrants and may continue to do so in the future. The conversion and/or exercise
of these securities and the sale of the shares of common stock issuable thereunder may dilute your percentage ownership interest
and may also result in downward pressure on the price of our common stock; and
●
we may engage in future
acquisitions or strategic transactions, which may require us to seek additional financing or financial commitments, increase our
expenses and/or present significant distractions to our management.
Risks Related to
Our Financial Position and Need for Capital
Our financial
situation creates doubt whether we will continue as a going concern.
The
Company was incorporated on September 28, 2017, and through the date of this report has generated no significant revenues. For the years
ended December 31, 2025, and 2024, the Company had a net loss of $42,787,043 and $35,020,058, respectively. There can be no assurances
that we will be able to achieve a level of revenues adequate to generate sufficient cash flow from operations or additional financing
through private placements, public offerings and/or bank financing necessary to support our working capital requirements. To the extent
that funds generated from any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional
working capital. No assurance can be given that additional financing will be available, or if available, will be on acceptable terms.
These conditions raise substantial doubt about our ability to continue as a going concern. If adequate working capital is not available,
we may be forced to discontinue operations, which would cause investors to lose their entire investment.
Our ability to
have our securities traded on the Nasdaq Capital Market is subject to us meeting applicable listing criteria.
As previously reported in a Current Report on
Form 8-K filed by the Company, on December 1, 2025, the Company received written notice from the Listing Qualifications Department of
The Nasdaq Capital Market LLC stating that, based upon the stockholders’ equity reported by the Company in its Form 10-Q for the
period ended September 30, 2025, the Company was no longer in compliance with Nasdaq Listing Rule 5550(b)(1), which requires a company
to maintain a minimum of $2,500,000 in stockholders’ equity, a market value of listed securities of at least $35 million, or net
income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed
fiscal years. In accordance with the Nasdaq Listing Rules, the Company had 45 calendar days, or until January 15, 2026, to submit a plan
to regain compliance. The Company submitted its plan of compliance on January 15, 2026, and was granted an extension by Nasdaq until
May 15, 2026, to regain compliance. A delisting could materially and adversely affect our business, financial condition and results of
operations and could reduce the liquidity and market price of our common stock.
Although Nasdaq granted the extension, we must
satisfy the requirements for continued listing by the end of the extension period. Our ability to regain compliance may depend on factors
that are outside our control, including market conditions, our operating performance, our ability to improve our stockholders’
equity, and our ability to access capital on acceptable terms, if at all. In addition, Nasdaq may require that we meet interim milestones
or other conditions during the extension period, and there can be no assurance that we will satisfy any such conditions. Even if we regain
compliance, Nasdaq may subsequently determine that we fail to satisfy other continued listing requirements, and we may again become subject
to delisting.
As of the date of this Annual Report, our common
stock has traded below $1.00 for 6 consecutive trading days. Under Nasdaq’s continued listing requirements, if our common stock
trades below $1.00 for 30 consecutive trading days, we would be subject to a minimum bid price deficiency and Nasdaq would generally
provide notice that we are not in compliance. As of the date of this Annual Report, we have not received a deficiency notice from Nasdaq;
however, there can be no assurance that we will not receive such notice if our common stock continues to trade below the minimum bid
price threshold for the required period.
14
In addition, on January 26, 2026, Nasdaq filed a rule proposal with
the SEC that, if approved and implemented, could require the immediate suspension and delisting of companies whose market capitalization
falls below a specified minimum threshold, including a proposed threshold of $5.0 million, for 30 consecutive business days. On March
11, 2026, the SEC issued a release extending the period to approve, disapprove or institute proceedings to determine whether to disapprove
the proposed new continued listing standard from March 16, 2026 to April 29, 2026. Because the rule is proposed, it may be modified, delayed
or not adopted, and any final rule could differ materially from the proposal, including with respect to the applicable market capitalization
test, measurement period, cure period, compliance deadlines, and available remedies. However, if a minimum market capitalization requirement
at or near the proposed level is adopted and becomes applicable to us, and our market capitalization falls below the applicable threshold
for the relevant period, we could be deemed noncompliant and become subject to delisting from Nasdaq.
Our market capitalization has fluctuated in the past and may continue
to fluctuate significantly due to factors beyond our control, including overall market conditions, volatility in the trading price or
volume of our common stock, industry developments, the availability of research coverage, and investor sentiment. In addition, events
such as equity issuances, reverse stock splits, or other corporate actions may not increase our market capitalization and could adversely
affect it. As of March 30, 2026, our market capitalization is approximately $713,000. As a result, there can be no assurance that we would
be able to satisfy any new minimum market capitalization continued listing standard, if adopted.
Unlike most Nasdaq continued listing deficiencies,
the proposed rule would allow suspension and delisting to take effect without a prior hearing and without any automatic stay. Although
an affected company could seek review of a delisting determination and appeal to the Nasdaq Listing and Hearing Review Council, its securities
would remain suspended from Nasdaq trading during that process and would generally trade in the over-the-counter market. The scope of
any hearing would be narrowly limited to whether Nasdaq staff made a factual error, with no discretion to grant additional time or consider
subsequent compliance.
If our common stock
were delisted from Nasdaq, we could face significant adverse consequences, including: reduced trading liquidity; increased volatility;
reduced analyst coverage and diminished investor interest; decreased ability to raise capital; and potential defaults, penalties or other
adverse consequences under agreements that include listing-related covenants or that are affected by a reduced trading market. Delisting
could also impair our ability to use equity or equity-linked securities for strategic transactions, employee compensation and other corporate
purposes, and could increase our cost of capital. If our common stock were to trade on an over-the-counter market, the market price and
liquidity of our common stock could be adversely affected and investors may have difficulty selling their shares.
We have generated
no significant revenue from commercial sales to date and our future profitability is uncertain.
We
were incorporated in September 2017 and have a limited operating history and our business is subject to all of the risks inherent in the
establishment of a new business enterprise. Our likelihood of success must be considered in light of the problems, expenses, difficulties,
complications and delays frequently encountered in connection with development and expansion of a new business enterprise. Since inception,
we have incurred losses and expect to continue to operate at a net loss for at least the next several years as we commence our research
and development efforts, conduct clinical trials and develop manufacturing, sales, marketing and distribution capabilities. Our net loss
for the years ended December 31, 2025 and 2024 was $42,787,043 and $35,020,058, respectively, and our accumulated deficit as of December
31, 2025 was $209,808,770. There can be no assurance that the products under development by us will be approved for sale in the U.S. or
elsewhere. Furthermore, there can be no assurance that if such products are approved, they will be successfully commercialized, and the
extent of our future losses and the timing of our profitability are highly uncertain. If we are unable to achieve profitability, we may
be unable to continue our operations.
If we fail to
obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and you will likely
lose your entire investment.
We will need to continue
to seek capital from time to time to continue development of our lead drug candidate beyond our initial combined Phase I/IIa clinical
trial and to acquire and develop other product candidates. Once approved for commercialization, we cannot provide any assurances that
any revenues it may generate in the future will be sufficient to fund our ongoing operations.
Our business or operations
may change in a manner that would consume available funds more rapidly than anticipated and substantial additional funding may be required
to maintain operations, fund expansion, develop new or enhance products, acquire complementary products, business or technologies or
otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred
treatment modalities. In addition, we may need to accelerate the growth of our sales capabilities and distribution beyond what is currently
envisioned, and this would require additional capital. However, we may not be able to secure funding when we need it or on favorable
terms. We may not be able to raise sufficient funds to commercialize the product candidates we intend to develop.
15
If we cannot raise adequate
funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development activities, clinical
studies or future operations. We may also be required to obtain funds through arrangements with collaborators, which arrangements may
require us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing, including rights
to future product candidates or certain major geographic markets. This could result in sharing revenues which we might otherwise retain
for ourselves. Any of these actions may harm our business, financial condition and results of operations.
The amount of capital
we may need depends on many factors, including the progress, timing and scope of our product development programs; the progress, timing
and scope of our preclinical studies and clinical trials; the time and cost necessary to obtain regulatory approvals; the time and cost
necessary to further develop manufacturing processes and arrange for contract manufacturing; our ability to enter into and maintain collaborative,
licensing and other commercial relationships; and our partners’ commitment of time and resources to the development and commercialization
of our products.
We may need to
raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed
may force us to delay, limit or terminate our product development efforts or other operations.
We do not expect that
our current cash position will be sufficient to fund our current operations for the next 12 months. Our operating plan may change as
a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private
equity or debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations,
strategic alliances and licensing arrangements or a combination of these approaches. In any event, we will require additional capital
to obtain regulatory approval for, and to commercialize, our product candidates. Raising funds in the current economic environment may
present additional challenges. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional
capital if market conditions are favorable or if we have specific strategic considerations.
Any additional fundraising
efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize
our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable
to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance
of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares
to decline. The sale of additional equity or convertible securities may dilute our existing stockholders. The incurrence of indebtedness
would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations
on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other
operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through
arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to
relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have
a material adverse effect on our business, operating results and prospects.
If we are unable to
obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development
programs or the commercialization of any product candidate or be unable to expand our operations or otherwise capitalize on our business
opportunities, as desired, which could materially affect our business, financial condition and results of operations.
Even if we can
raise additional funding, we may be required to do so on terms that are dilutive to you.
The capital markets
have been unpredictable in the past for unprofitable companies such as ours. In addition, it is generally difficult for development stage
companies to raise capital under current market conditions. The amount of capital that a company such as ours is able to raise often
depends on variables that are beyond our control. As a result, we may not be able to secure financing on terms attractive to us, or at
all. If we are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs. If adequate
funds are not available on acceptable terms, or at all, our business, including our results of operations, financial condition and our
continued viability will be materially adversely affected.
16
Risks Related to
Product Development, Regulatory Approval, Manufacturing and Commercialization
The regulatory
approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of
our future product candidates, if any.
We will not be permitted
to market our product candidates in the United States until we receive approval from the FDA, or in any foreign countries until we receive
the requisite approval from corresponding agencies in such countries. The testing, manufacturing, labeling, approval, selling, marketing
and distribution of health and life science-related products are subject to extensive regulation, which regulations differ from country
to country.
Successfully completing
our clinical program and obtaining approval of a Biologics License Application (“BLA”) is a complex, lengthy, expensive and
uncertain process, and the FDA or other applicable foreign regulator may delay, limit or deny approval of our product candidates for
many reasons, including, among others, because:
● we
may not be able to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA
or foreign regulator;
●
the results
of our clinical trials may not meet the level of statistical or clinical significance required by the FDA or foreign regulator for
marketing approval;
●
the FDA or
foreign regulator may disagree with the number, design, size, conduct or implementation of our clinical trials;
●
the FDA or
foreign regulator may require that we conduct additional clinical trials;
●
the FDA or
foreign regulator may not approve the formulation, labeling or specifications of our product candidates;
●
the contract
research organizations (CROs) and other contractors that we may retain to conduct our clinical trials may take actions outside of
our control that materially adversely impact our clinical trials;
●
the FDA or
foreign regulator may find the data from preclinical studies and clinical trials insufficient to demonstrate that our product candidate(s)
are safe and effective for their proposed indications;
●
the FDA or
foreign regulator may disagree with our interpretation of data from our preclinical studies and clinical trials;
●
the FDA or
foreign regulator may not accept data generated at our clinical trial sites or may disagree with us over whether to accept efficacy
results from clinical trial sites outside the United States or outside the EU, as applicable, where the standard of care is potentially
different from that in the United States or in the EU, as applicable;
●
if and when
our BLAs or foreign equivalents are submitted to the applicable regulatory authorities, such agencies may have difficulties scheduling
the necessary review meetings in a timely manner, may recommend against approval of our application or may recommend or require,
as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and
use restrictions;
●
the FDA or
foreign regulator may require development of a Risk Evaluation and Mitigation Strategy (REMS), which would use risk minimization
strategies to ensure that the benefits of certain prescription drugs outweigh their risks, as a condition of approval or post-approval;
●
the FDA or
other applicable foreign regulatory agencies may not approve the manufacturing processes or facilities of third-party manufacturers
with which we contract; or
●
the FDA or
the other applicable foreign regulatory agencies may change their approval policies or adopt new regulations.
17
We may encounter
substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate
safety and efficacy to the satisfaction of applicable regulatory authorities.
It is difficult to predict
if or when any of our product candidates, will prove safe or effective in humans or will receive regulatory approval. Before
obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies
to demonstrate the safety and efficacy of the product candidates in humans. Clinical testing is expensive, time-consuming and uncertain
as to outcome. We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. A failure
of one or more clinical studies can occur at any stage of testing. Events that may prevent successful or timely completion of clinical
development include:
●
delays in reaching,
or failing to reach, a consensus with regulatory agencies on study design;
●
delays in reaching,
or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations (“CROs”)
and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs
and trial sites;
●
delays in obtaining required
Institutional Review Board (“IRB”) or Ethics Committee (“EC”) approval at each clinical study site;
●
delays in recruiting a
sufficient number of suitable patients to participate in our clinical studies;
●
imposition of a clinical
hold by regulatory agencies, after an inspection of our clinical study operations or study sites;
●
failure by
our CROs, other third parties or us to adhere to the clinical study, regulatory or legal requirements;
●
failure to perform in accordance
with the FDA’s good clinical practices (“GCP”) or applicable regulatory guidelines in other countries;
●
delays in the
testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;
●
delays in having patients’
complete participation in a study or return for post-treatment follow-up;
●
clinical study sites or
patients dropping out of a study;
●
delay or failure to address
any patient safety concerns that arise during the course of a trial;
●
unanticipated costs or
increases in costs of clinical trials of our product candidates;
●
occurrence of serious adverse
events associated with the product candidates that are viewed to outweigh their potential benefits; or
●
changes in regulatory requirements
and guidance that require amending or submitting new clinical protocols.
We could also encounter
delays if a clinical trial is suspended or terminated by us, by the IRBs or ECs of the institutions in which such trials are being conducted,
by an independent Safety Review Board (“SRB”) for such trial or by the FDA, European Medicines Agency (“EMA”),
or other regulatory authorities. Such authorities may suspend or terminate a clinical trial due to a number of factors, including
failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical
trial operations or trial site by the FDA, EMA, or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen
safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative
actions or lack of adequate funding to continue the clinical trial.
Any inability to successfully
complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenues from
product sales, regulatory and commercialization milestones and royalties. In addition, if we make manufacturing or formulation changes
to our product candidates, we may need to conduct additional studies to bridge our modified product candidates to earlier versions.
18
Clinical study delays
could also shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors
to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates. In
addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development
and approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may significantly
harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement
or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.
The outcome of preclinical
studies and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial
do not necessarily predict final results. Further, preclinical and clinical data are often susceptible to various interpretations and
analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical
trials have, nonetheless, failed to obtain marketing approval. If the results of our clinical studies are inconclusive or if there
are safety concerns or adverse events associated with our other product candidates, we may:
● be
delayed in obtaining marketing approval for our product candidates, if approved at all;
●
obtain approval
for indications or patient populations that are not as broad as intended or desired;
●
obtain approval with labeling
that includes significant use or distribution restrictions or safety warnings;
●
be required
to change the way the product is administered;
●
be required to perform
additional clinical studies to support approval or be subject to additional post-marketing testing requirements;
●
have regulatory authorities
withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation
strategy;
●
be sued; or
●
experience damage to our
reputation.
Additionally, our product
candidates could potentially cause other adverse events that have not yet been predicted. The inclusion of ill patients in our clinical
studies may result in deaths or other adverse medical events due to other therapies or medications that such patients may be using. As
described above, any of these events could prevent us from achieving or maintaining market acceptance of our product candidates and impair
our ability to commercialize our products.
If our future
pre-clinical development and future clinical Phase I/II studies are unsuccessful, we may be unable to obtain regulatory approval of,
or commercialize, our product candidates on a timely basis or at all.
The successful completion
of pre-clinical development and multiple clinical trials is critical to the success of our future products. If the pre-clinical development
and clinical trials are unsuccessful or produce inconsistent results or unanticipated adverse side effects, or if we are unable to collect
reliable data, regulatory approval of our products could be delayed or not given and as a result we may be unable to commercialize our
products. Generally, we expect to engage third parties such as consultants, universities or other collaboration partners to conduct clinical
trials on our behalf. Incompatible practices or misapplication of our products by these third parties could impair the success of our
clinical trials.
19
Even if we receive
regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that
we generate from their sales, if any, may be limited.
If approved for marketing,
the commercial success of our product candidates will depend upon each product’s acceptance by the medical community, including
physicians, patients and health care payors. The degree of market acceptance for any of our product candidates will depend on a number
of factors, including:
●
demonstration
of clinical safety and efficacy;
●
relative convenience, dosing
burden and ease of administration;
●
the prevalence and severity
of any adverse effects;
●
the willingness of physicians
to prescribe our product candidates, and the target patient population to try new therapies;
●
efficacy of
our product candidates compared to competing products;
●
the introduction of any
new products that may in the future become available targeting indications for which our product candidates may be approved;
●
new procedures or therapies
that may reduce the incidences of any of the indications in which our product candidates may show utility;
●
pricing and
cost-effectiveness;
●
the inclusion or omission
of our product candidates in applicable therapeutic and vaccine guidelines;
●
the effectiveness of our
own or any future collaborators’ sales and marketing strategies;
●
limitations
or warnings contained in approved labeling from regulatory authorities;
●
our ability to obtain and
maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid,
private health insurers and other third-party payors or to receive the necessary pricing approvals from government bodies regulating
the pricing and usage of therapeutics; and
●
the willingness of patients
to pay out-of-pocket in the absence of third-party coverage or reimbursement or government pricing approvals.
If any of our product
candidates are approved, but do not achieve an adequate level of acceptance by physicians, health care payors, and patients, we may not
generate sufficient revenues and we may not be able to achieve or sustain profitability. Our efforts to educate the medical community
and third-party payors on the benefits of our product candidates may require significant resources and may never be successful.
20
In addition, even if
we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize our product
candidates successfully. For example, if the approval process takes too long, we may miss market opportunities and give other companies
the ability to develop competing products or establish market dominance. Any regulatory approval we ultimately obtain may be limited
or subject to restrictions or post-approval commitments that render our product candidates not commercially viable. For example, regulatory
authorities may approve any of our product candidates for fewer or more limited indications than we request, may grant approval contingent
on the performance of costly post-marketing clinical trials, or may approve any of our product candidates with a label that does not
include the labeling claims necessary or desirable for the successful commercialization for that indication. Further, the FDA or comparable
foreign regulatory authorities may place conditions on approvals or require risk management plans or a Risk Evaluation and Mitigation
Strategy (“REMS”) to assure the safe use of the drug. If the FDA or applicable foreign regulatory agency concludes a REMS
is needed, the sponsor of the BLA must submit a proposed REMS; the regulatory agencies will not approve the BLA without an approved REMS,
if required. A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted
distribution methods, patient registries and other risk minimization tools. The regulatory agencies may also require a REMS for an approved
product when new safety information emerges. Any of these limitations on approval or marketing could restrict the commercial promotion,
distribution, prescription or dispensing of our product candidates. Moreover, product approvals may be withdrawn for non-compliance with
regulatory standards or if problems occur following the initial marketing of the product. Any of the foregoing scenarios could materially
harm the commercial success of our product candidates.
Adverse events
involving our products may lead the FDA or applicable foreign regulatory agency to delay or deny clearance for our products or result
in product recalls that could harm our reputation, business and financial results.
Once a product receives
regulatory clearance or approval, the agency has the authority to require the recall of commercialized products in the event of adverse
side effects, material deficiencies or defects in design or manufacture. The authority to require a recall must be based on a regulatory
finding that there is a reasonable probability that the product would cause serious injury or death. Manufacturers may, under their own
initiative, recall a product if any material deficiency in a product is found. A government-mandated or voluntary recall by us or one
of our distributors could occur as a result of adverse side effects, impurities or other product contamination, manufacturing errors,
design or labeling defects or other deficiencies and issues. Recalls of any of our products would divert managerial and financial resources
and have an adverse effect on our financial condition and results of operations. The regulatory agencies require that certain classifications
of recalls be reported to them within ten (10) working days after the recall is initiated. Companies are required to maintain certain
records of recalls, even if they are not reportable to the regulatory agency. We may initiate voluntary recalls involving our products
in the future that we determine do not require notification of the regulatory agencies. If the regulatory agency disagrees with our determinations,
they could require us to report those actions as recalls. A future recall announcement could harm our reputation with customers and negatively
affect our sales. In addition, the regulatory agency could take enforcement action for failing to report the recalls when they were conducted.
The in-licensing
of technologies and the successful testing and early development of technologies in the laboratory may not be indicative of future results
and may not result in commercially viable technologies or products. Further, our future products may have to be modified from their originally
conceived versions in order to reach or be successful in the market.
Positive results from
laboratory testing and early developmental successes, may not be predictive of future successful development, commercialization and sales
results and should not be relied upon as evidence that products developed from our technologies will become commercially viable and successful.
Further, the products we plan to develop in the future may have to be significantly modified from their originally conceived versions
in order for us to control costs, compete with similar products, receive market acceptance, meet specific development and commercialization
timeframes, avoid potential infringement of the proprietary rights of others, or otherwise succeed in developing our business and earning
ongoing revenues. This can be a costly and resource draining activity. What appear to be promising technologies when we license them
may not lead to viable technologies or products, or to commercial success.
21
Complying with
numerous regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in
substantial penalties.
We are subject to the
Clinical Laboratory Improvement Amendment of 1988, or CLIA, which is a federal law regulating clinical laboratories that perform testing
on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. Our
clinical laboratory is located in Richmond, Virginia and must be certified under CLIA in order for us to perform testing on human specimens.
CLIA is intended to ensure the quality and reliability of clinical laboratories in the United States by mandating specific standards
in the areas of personnel qualifications, administration, and participation in proficiency testing, patient test management, quality
control, quality assurance and inspections. We currently hold a CLIA certificate to perform high-complexity testing. Laboratories performing
high complexity testing are required to meet more stringent requirements than laboratories performing less complex tests. CLIA regulations
require clinical laboratories like ours to comply with various operational, personnel, facilities administration, quality, and proficiency
testing requirements intended to ensure that testing services are accurate, reliable and timely. CLIA certification is a prerequisite
for reimbursement eligibility for services provided to state and federal health care program beneficiaries. CLIA is user-fee funded.
Therefore, all costs of administering the program must be covered by the regulated facilities, including certification and survey costs.
To renew this certificate, we are subject to survey and inspection every two years. Moreover, CLIA inspectors may make periodic inspections
of our clinical laboratory outside of the renewal process. The failure to comply with CLIA requirements can result in enforcement actions,
including the revocation, suspension, or limitation of our CLIA certificate of compliance, as well as a directed plan of correction,
state on-site monitoring, civil money penalties, civil injunctive suit and/or criminal penalties. We must maintain CLIA compliance and
certification to be eligible to bill for assays provided to Medicare beneficiaries. If we were to be found out of compliance with CLIA
program requirements and subjected to sanctions, our business and reputation could be harmed. Even if it were possible for us to bring
our laboratory back into compliance, we could incur significant expenses and potentially lose revenue in doing so.
Additionally, certain
states require laboratory licenses in order to test specimens from patients in those states or received from ordering physicians in those
states. We may also be subject to regulation in foreign jurisdictions if we seek to expand international distribution of our assays outside
the United States.
If we were to lose our
CLIA certification or state laboratory licenses, whether as a result of a revocation, suspension or limitation, we would no longer be
able to offer our assays (including our AditxtScore™ platform), which would limit our revenues and harm our business. If we were
to lose, or fail to obtain, a license in any other state where we are required to hold a license, we would not be able to test specimens
from those states.
Risks Related to
the Company and our Business
Certain technologies
are subject to licenses from LLU and Stanford, each of which are revocable in certain circumstances, including in the event we do not
achieve certain payments and milestone deadlines. Without these licenses, we may not be able to continue to develop our product candidates.
The LLU License Agreement
may be terminated by LLU in the event of a breach by us of any non-payment provision (including the provision that requires us to meet
certain deadlines for milestone events (each, a “Milestone Deadline”)) not cured within 90 days after delivery of written
notice by LLU. Additional Milestone Deadlines include: (i) the requirement to have regulatory approval of an IND application to initiate
first-in-human clinical trials on or before March 31, 2023 (which has been extended to March 31, 2024 with a payment of a $100,000 extension
fee), (ii) the completion of first-in-human (phase I/II) clinical trials by March 31, 2024, (iii) the completion of Phase III clinical
trials by March 31, 2026 and (iv) biologic licensing approval (BLA) by the FDA by March 31, 2027. If the LLU License Agreement were to
be terminated by LLU, we would lose our most significant asset and may no longer be able to develop our product candidates, which would
have a material adverse effect on our operations.
The February 2020 License
Agreement with Stanford may be terminated by Stanford if we (i) are delinquent on any report or payments; (ii) are not diligently developing
and commercializing Licensed Product (as defined in the February 2020 License Agreement); (iii) miss a milestone described in the agreement;
(iv) are in breach of any other provision of the agreement; or (v) if we provide a false report to Stanford. The Termination discussed
above will take effect only upon 30 days written notice by Stanford unless we remedy the breach within a 30-day cure period. If the February
2020 License Agreement were to be terminated by Stanford, we would lose a significant asset and may no longer be able to develop our
product candidates, which would have a material adverse effect on our operations. The Company is current with its obligations and has
submitted a year end report as well as provided additional milestone plans for research and development as well as commercialization.
22
Our results of
operations will be affected by the level of royalty and milestone payments that we are required to pay to third parties.
The LLU License Agreement
and February 2020 License Agreement with Stanford each require us to remit royalty payments and meet certain performance milestones related
to in-licensed intellectual property. Any failure on our part to pay royalties owed or meet milestones could lead to us losing rights
under our licenses and could thereby adversely affect our business. As our product sales increase, we may, from time-to-time, disagree
with our third-party collaborators as to the appropriate royalties owed and the resolution of such disputes may be costly and may consume
management’s time. Furthermore, we may enter into additional license agreements in the future, which may also include royalty payments.
We face substantial
competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
The development and
commercialization of drugs is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized
biotechnology companies, as well as products and processes being developed at universities and other research institutions. Our competitors
have developed, are developing or will develop product candidates and processes competitive with our product candidates. Competitive
therapeutic treatments include those that have already been approved and accepted by the medical community and any new treatments that
may enter the market. We believe that a significant number of products are currently available, under development, and may become commercially
available in the future, for the treatment of indications for which we may try to develop product candidates.
More established companies
may have a competitive advantage over us due to their greater size, cash flows and institutional experience. Compared to us, many of
our competitors may have significantly greater financial, technical and human resources. As a result of these factors, our competitors
may have an advantage in marketing their approved products and may obtain regulatory approval of their product candidates before we are
able to, which may limit our ability to develop or commercialize our product candidates. Our competitors may also develop drugs that
are safer, more effective, more widely used and less expensive than ours, and may also be more successful than us in manufacturing and
marketing their products.
Mergers and acquisitions
in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our
competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large and established companies. These companies compete with us in recruiting and retaining qualified scientific,
management and commercial personnel, establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring
technologies complementary to, or necessary for, our programs.
Our technologies
and products under development, and our business, may fail if we are not able to successfully commercialize them and ultimately generate
significant revenues as a result.
Successful development
of technologies and our product candidates will require significant additional investment, including costs associated with additional
development, completing trials and obtaining regulatory approval, as well as the ability to manufacture or have others manufacture our
products in sufficient quantities at acceptable costs while also preserving product quality. Difficulties often encountered in scaling
up production include problems involving production yields, quality control and assurance, shortage of qualified personnel, production
costs and process controls. In addition, we are subject to inherent risks associated with new technologies and products. These risks
include the possibility that any of our technologies or future products may:
●
be found unsafe;
●
be ineffective
or less effective than anticipated;
●
fail to receive
necessary regulatory approvals;
●
be difficult
to competitively price relative to alternative solutions;
●
be harmful
to consumers or the environment;
●
be difficult
to manufacture on an economically viable scale;
●
be subject
to supply chain constraints for raw materials;
23
●
fail to be
developed and accepted by the market prior to the successful marketing of alternative products by competitors;
●
be difficult
to market because of infringement on the proprietary rights of third parties; or
●
be too expensive
for commercial use.
Furthermore, we may
be faced with lengthy market partner or distributor evaluation and approval processes. Consequently, we may incur substantial expenses
and devote significant management effort in order to customize products for market partner or distributor acceptance, though there can
be no assurance of such acceptance. As a result, we cannot accurately predict the volume or timing of any future sales.
Customers may
not adopt our products quickly, or at all.
Customers in the sector
in which we operate can be generally cautious in their adoption of new products and technologies. In addition, given the relative novelty
of our future planned products (including our AditxtScore™ platform), customers of those products may require education regarding
their utility and use, which may delay their adoption. There can be no assurance that customers will adopt our products quickly, or at
all.
The significant
level of competition in the markets for our products developed in the future may result in pricing pressure, reduced margins or the inability
of our future products to achieve market acceptance.
The markets for our
future products are intensely competitive and rapidly changing. We may be unable to compete successfully, which may result in price reductions,
reduced margins and the inability to achieve market acceptance for our products.
Our competitors may
have longer operating histories, significantly greater resources, greater brand recognition and large customer bases than we do. As a
result, they may be able to devote greater resources to the manufacture, promotion or sale of their products, receive greater resources
and support from market partners and independent distributors, initiate or withstand substantial price competition or more readily take
advantage of acquisition or other opportunities.
We rely on third
parties for the distribution of our current and future products, including our AditxtScore™ platform. If these parties do
not distribute our products in a satisfactory or timely manner, in sufficient quantities or at an acceptable cost, our sales and development
efforts could be delayed or otherwise negatively affected.
We rely on third parties
for the distribution of our current and future products, including our AditxtScore™ platform. Our reliance on third parties to
distribute products may present significant risks to us, including the risk that should any of these third parties fail to adequately
distribute our products and services to end consumers and other market participants, our business may be materially harmed. Additionally,
if we need to enter into agreements for the distribution of our future products with other third parties, there can be no assurance we
will be able to do so on favorable terms, if at all.
We may rely on
third parties for the production of our future products. If these parties do not produce our products at a satisfactory quality,
in a timely manner, in sufficient quantities or at an acceptable cost, our sales and development efforts could be delayed or otherwise
negatively affected.
We may rely on third
parties for the manufacture of our future products. Our reliance on third parties to manufacture our future products may present significant
risks to us, including the following:
●
reduced control
over delivery schedules, yields and product reliability;
●
price increases;
●
manufacturing
deviations from internal and regulatory specifications;
●
the failure
of a key manufacturer to perform as we require for technical, market or other reasons;
24
●
difficulties
in establishing additional manufacturer relationships if we are presented with the need to transfer our manufacturing process technologies
to them;
●
misappropriation
of our intellectual property; and
●
other risks
in potentially meeting our product development schedule or satisfying the requirements of our market partners, distributors, direct
customers and end users.
If we need to enter
into agreements for the manufacturing of our future products, there can be no assurance we will be able to do so on favorable terms,
if at all.
If we are unable
to establish successful relations with third-party market partners or distributors, or these market partners or distributors do not focus
adequate resources on selling our products or are otherwise unsuccessful in selling them, sales of our products may not develop.
We anticipate relying
on independent market partners and distributors to distribute and assist us with the marketing and sale of our products. Our future revenue
generation and growth will depend in large part on our success in establishing and maintaining this sales and distribution channel. If
our market partners and distributors are unable to sell our products, or receive negative feedback from end users, they may not continue
to purchase or market our products. In addition, there can be no assurance that our market partners and distributors will focus adequate
resources on selling our products to end users or will be successful in selling them. Many of our potential market partners and distributors
are in the business of distributing and sometimes manufacturing other, possibly competing, products. As a result, these market partners
and distributors may perceive our products as a threat to various product lines currently being distributed or manufactured by them.
In addition, these market partners and distributors may earn higher margins by selling competing products or combinations of competing
products. If we are unable to establish successful relationships with independent market partners and distributors, we will need to further
develop our own sales and distribution capabilities, which would be expensive and time-consuming and might not be successful.
If we are not
able to attract and retain highly skilled employees and contractors, we may not be able to implement our business model successfully.
We will rely upon employees
and third-party consultant/contractors to effectively establish, manage and grow our business. Consequently, we believe that our future
viability will depend largely on our ability to attract and retain highly skilled personnel. In order to do so, we may need to pay
higher compensation, fees, and/or other incentives to our employees or consultants than we currently expect, and such higher compensation
payments would have a negative effect on our operating results. Competition for experienced, high-quality employees, consultants and
contractors is intense and we cannot assure that we will be able to recruit and retain such personnel. We may not be able to hire or
retain the necessary personnel to implement our business strategy. Our failure to hire and retain such personnel could impair our ability
to develop new products and manage our business effectively.
The loss of our
management team or other key personnel would have an adverse impact on our future development and impair our ability to succeed.
In the early stages
of development, our business will be significantly dependent on the Company’s management team and other key personnel. Our success
will be particularly dependent upon our Chief Executive Officer, Mr. Amro Albanna and our Chief Innovation Officer, Dr. Shahrokh Shabahang.
The loss of any one of these individuals or any other future key personnel could have a material adverse effect on the Company and our
ability to further execute our intended business.
25
The commercial
success of our in-development and future diagnostic tests and services depends upon attaining significant market acceptance among payers,
providers, clinics, patients, and biopharmaceutical companies.
Our commercial success
depends, in part, on the acceptance of our diagnostic tests and services as being safe and relatively simple for medical personnel to
learn and use, clinically flexible, operationally versatile and, with respect to providers and payers, cost effective. We cannot predict
how quickly, if at all, payers, providers, clinics and patients will accept future diagnostic tests and services or, if accepted, how
frequently they will be used. These constituents must believe that our diagnostic tests offer benefits over other available alternatives.
The degree of market
acceptance of our in development and future diagnostic tests and services depends on a number of factors, including:
●
whether there
is adequate utilization of our tests by clinicians, biopharmaceutical companies and other target groups based on the potential and
perceived advantages of our diagnostic tests over those of our competitors;
●
the convenience
and ease of use of our diagnostic tests relative to those currently on the market;
●
the effectiveness
of our sales and marketing efforts;
●
the ability
of our distribution partners to meet sales forecasts;
●
our ability
to provide incremental data that show the clinical benefits and cost effectiveness, and operational benefits, of our diagnostic tests;
●
the coverage
and reimbursement acceptance of our products and services;
●
pricing pressure,
including from group purchasing organizations (GPOs), seeking to obtain discounts on our diagnostic tests based on the collective
bargaining power of the GPO members;
●
negative publicity
regarding our or our competitors’ diagnostic tests resulting from defects or errors;
●
the accuracy
of our tests relative to those of our competitors;
●
ability to
obtain any requisite premarket authorization from FDA prior to commercializing our tests;
●
product labeling
or product insert requirements by the FDA or other regulatory authorities; and
●
limitations
or warnings contained in the labeling cleared or approved by the FDA or other authorities.
The use of our
products may be limited by regulations, and we may be exposed to product liability and remediation claims.
The use of our planned
products may be regulated by various local, state, federal and foreign regulators. Even if we are able to comply with all such regulations
and obtain all necessary registrations, we cannot provide assurance that our future products will not cause injury to the environment,
people, or animals and/or otherwise have unintended adverse consequences, under all circumstances. For example, our products may be improperly
combined with other chemicals or, even when properly combined, our products may be blamed for damage caused by those other chemicals.
The costs of remediation or products liability could materially adversely affect our results, financial condition and operations.
26
We may be held
liable for, or incur costs to settle, liability and remediation claims if any products we develop, or any products that use or incorporate
any of our technologies, cause injury or are found unsuitable during product testing, manufacturing, marketing, sale or use. These risks
exist even with respect to products that have received, or may in the future receive, regulatory approval, registration or clearance
for commercial use. We cannot guarantee that we will be able to avoid product liability exposure.
At the stage customary
to do so, we expect to maintain product liability insurance at levels we believe are sufficient and consistent with industry standards
for like companies and products. However, we cannot guarantee that our product liability insurance will be sufficient to help us avoid
product liability-related losses. In the future, it is possible that meaningful insurance coverage may not be available on commercially
reasonable terms or at all. In addition, a product liability claim could result in liability to us greater than our assets or insurance
coverage. Moreover, even if we have adequate insurance coverage, product liability claims or recalls could result in negative publicity
or force us to devote significant time and attention to these matters, which could harm our business.
Our ability to
offer new products and continue the development of our existing products, depends upon us maintaining strong relationships with health
care professionals.
If we fail to maintain
our working relationships with health care professionals, many of our products may not be developed and offered in line with the needs
and expectations of the professionals who use and support our products, which could cause a decline in our earnings and profitability.
The research, development, marketing, and sales of our products is expected to be dependent upon our maintaining working relationships
with such health care professionals, and the use of our products is expected to often require the participation of health care professionals.
In addition, health care professionals are the primary customer groups we expect to market and sell our products directly to, further
highlighting the importance of our relationship with such health care professionals. If we are unable to maintain our relationships with
these professionals, we may lose our primary customer base, our products may not be utilized correctly or to their full potential, and
our ability to develop, manufacture, and market future products may be significantly stunted.
We operate in
a highly competitive industries and we may be unable to compete effectively.
We expect to compete
domestically and internationally in the neurology, diagnostic imaging and MedTech markets and the motion control market. These markets
are characterized by rapid change resulting from technological advances and scientific discoveries. In the product lines and offered
services in which we plan to compete, we face a mixture of competitors ranging from large manufacturers with multiple business lines
to small manufacturers that offer a limited selection of niche products. Development by other companies of new or improved products,
processes, technologies, or the introduction of reprocessed products or generic versions when our proprietary products lose their patent
protection may make our existing products or proposed products less competitive. Competitive factors include product reliability, product
performance, product technology, product quality, breadth of product lines, product services, customer support, price, and reimbursement
approval from health care insurance providers.
We also face competition
for marketing, distribution, and collaborative development agreements, for establishing relationships health care professionals, medical
associations, and academic and research institutions, and for licenses to intellectual property. In addition, academic institutions,
governmental agencies and other public and private research organizations also may conduct research, seek patient protection and establish
collaborative arrangements for discovery, research, clinical development and marketing of products similar to ours. These companies,
professionals, and institutions compete with us in recruiting and retaining qualified scientific and management personnel, as well as
in acquiring necessary product technologies.
There may be limitations
on the effectiveness of our internal controls, and a failure of our control systems to prevent error or fraud may materially harm our
Company.
We do not expect that
internal control over financial accounting and disclosure, even if timely and well established, will prevent all error and all fraud.
A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s
objectives will be met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits
of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of
controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. Failure of our control
systems to prevent error or fraud could materially adversely affect our business.
27
Risks Related to
Our Acquisition Strategy
Our acquisition
strategy exposes us to substantial risk.
Our acquisition of companies
is subject to substantial risk, including but not limited to the failure to identify material problems during due diligence (for which
we may not be indemnified post-closing), the risk of over-paying for assets (or not making acquisitions on an accretive basis), the ability
to obtain or retain customers and the risks of entering markets where we have limited experience. While we perform due diligence on prospective
acquisitions, we may not be able to discover all potential operational deficiencies in such entities.
Our acquisition targets
may not perform as expected or the returns from such businesses may not support the financing utilized to acquire them or maintain them.
Furthermore, integration and consolidation of acquired businesses requires substantial human, financial and other resources and may divert
management’s attention from our existing business concerns, disrupt our ongoing business or not be successfully integrated. Even
if we consummate businesses that we believe will be accretive, those businesses may in fact result in a decrease in revenues as a result
of incorrect assumptions in our evaluation of such businesses, unforeseen consequences, or other external events beyond our control.
Furthermore, if we consummate any future acquisitions, our capitalization and results of operations may change significantly, and stockholders
will generally not have the opportunity to evaluate the economic, financial, and other relevant information that we will consider in
determining the application of these funds and other resources. As a result, the consummation of acquisitions may have a material adverse
effect on our business, financial condition, results of operations and cash flows.
We may experience
difficulty as we evaluate, acquire and integrate businesses that we may acquire, which could result in drains on our resources, including
the attention of our management, and disruptions of our on-going business.
From time to time we
have acquired and may continue to acquire small to mid-sized businesses in various industry segments. Generally, because such businesses
may be privately held, we may experience difficulty in evaluating potential target businesses as much of the information concerning these
businesses is not publicly available. Therefore, our estimates and assumptions used to evaluate the operations, management and market
risks with respect to potential target businesses may be subject to various risks and uncertainties. Further, the time and costs associated
with identifying and evaluating potential target businesses may cause a substantial drain on our resources and may divert our management
team’s attention away from the operations of our businesses for significant periods of time.
In addition, we may
have difficulty effectively integrating and managing acquisitions. The management or improvement of businesses we acquire may be hindered
by a number of factors, including limitations in the standards, controls, procedures and policies implemented in connection with such
acquisitions. Further, the management of an acquired business may involve a substantial reorganization of the business’ operations
resulting in the loss of employees and customers or the disruption of our ongoing businesses. We may experience greater than expected
costs or difficulties relating to an acquisition, in which case, we might not achieve the anticipated returns from any particular acquisition.
We may not be
able to effectively integrate the businesses that we acquire.
Our ability to realize
the anticipated benefits of acquisitions will depend on our ability to integrate those businesses with our own. The combination of multiple
independent businesses is a complex, costly and time-consuming process and there can be no assurance that we will be able to successfully
integrate businesses into our business, or if such integration is successfully accomplished, that such integration will not be costlier
or take longer than presently contemplated. Integration of future acquisitions may include various risks and uncertainties, including
the factors discussed in the paragraph below. If we cannot successfully integrate and manage the businesses within a reasonable time,
we may not be able to realize the potential and anticipated benefits of such acquisitions, which could have a material adverse effect
on our stock price, business, cash flows, results of operations and financial position.
28
We will consider acquisitions
that we believe will complement, strengthen and enhance our growth. We evaluate opportunities on a preliminary basis from time to time,
but these transactions may not advance beyond the preliminary stages or be completed. Such acquisitions are subject to various risks
and uncertainties, including:
●
the inability
to integrate effectively the operations, products, technologies and personnel of the acquired companies (some of which are in diverse
geographic regions) and achieve expected synergies;
●
the potential
disruption of existing business and diversion of management’s attention from day-to-day operations;
●
the inability
to maintain uniform standards, controls, procedures and policies;
●
the need or
obligation to divest portions of the acquired companies;
●
the potential
failure to identify material problems and liabilities during due diligence review of acquisition targets;
●
the potential
failure to obtain sufficient indemnification rights to fully offset possible liabilities associated with acquired businesses; and
●
the challenges
associated with operating in new geographic regions.
The integration
of our acquisitions may result in significant accounting charges that adversely affect the announced results of our Company.
The financial results
of our Company may be adversely affected by cash expenses and non-cash accounting charges incurred in connection with our recent acquisitions.
In addition to the anticipated cash charges, costs associated with the amortization of intangible assets are expected. The price of our
common stock could decline to the extent our financial results are materially affected by the foregoing charges or if the foregoing charges
are larger than anticipated.
Our planned acquisitions
may result in unexpected consequences to our business and results of operations.
Although we believe
that our planned acquisitions will generally be subject to risks similar to those to which we are subject to in our existing operations,
we may not have discovered all risks applicable to these businesses during the due diligence process. Some of these risks could produce
unexpected and unwanted consequences for us. Undiscovered risks may result in us incurring financial liabilities, which could be material
and have a negative impact on our business operations.
Failure to manage
our growing and changing business could have a material adverse effect on our business, prospects, financial condition, and results of
operations.
As we grow, we expect
to encounter additional challenges to our internal processes, capital commitment process, and acquisition funding and financing capabilities.
Our existing operations, personnel, systems, and internal control may not be adequate to support our growth and expansion and may require
us to make additional unanticipated investments in our infrastructure. To manage the future growth of our operations, we will be required
to improve our administrative, operational, and financial systems, procedures, and controls, and maintain, expand, train, and manage
our growing employee base. If we are unable to manage our growth effectively, we may not be able to take advantage of market opportunities,
execute our business strategies successfully or respond to competitive pressures. As a result, our business, prospects, financial condition,
and results of operations could be materially and adversely affected.
29
We face competition
for businesses that fit our acquisition strategy and, therefore, we may have to acquire targets at sub-optimal prices or, alternatively,
forego certain acquisition opportunities.
Our acquisition strategy
is focused on the acquisition of small to mid-sized businesses. In pursuing such acquisitions, we expect to face strong competition from
a wide range of other potential purchasers. Although the pool of potential purchasers for such businesses is typically smaller than for
larger businesses, those potential purchasers can be aggressive in their approach to acquiring such businesses. Furthermore, we expect
that we will need to use third-party financing in order to fund some or all of these potential acquisitions, thereby increasing our acquisition
costs. To the extent that other potential purchasers do not need to obtain third-party financing or are able to obtain such financing
on more favorable terms, they may be in a position to be more aggressive with their acquisition proposals. As a result, in order to be
competitive, our acquisition proposals may need to be aggressively priced, including at price levels that exceed what we originally determined
to be fair or appropriate. Alternatively, we may determine that we cannot pursue on a cost-effective basis what would otherwise be an
attractive acquisition opportunity.
We may not be
able to successfully fund acquisitions due to the unavailability of equity or debt financing on acceptable terms, which could impede
the implementation of our acquisition strategy.
We intend to finance
acquisitions primarily through additional debt and equity financings. Because the timing and size of acquisitions cannot be readily predicted,
we may need to be able to obtain funding on short notice to benefit fully from attractive acquisition opportunities. The sale of additional
shares of any class of equity will be subject to market conditions and investor demand for such shares at prices that may not be in the
best interest of our stockholders. The sale of additional equity securities could also result in dilution to our stockholders. The incurrence
of indebtedness would result in increased debt service obligations and could require us to agree to operating and financial covenants
that would restrict our operations. Financing may not be available in amounts or on terms acceptable to us, if at all. These risks may
materially adversely affect our ability to pursue our acquisition strategy.
We may change
our management and acquisition strategies without the consent of our stockholders, which may result in a determination by us to pursue
riskier business activities.
We may change our strategy
at any time without the consent of our stockholders, which may result in our acquiring businesses or assets that are different from,
and possibly riskier than, the strategy described in this prospectus. A change in our strategy may increase our exposure to interest
rate and currency fluctuations, subject us to regulation under the Investment Company Act or subject us to other risks and
uncertainties that affect our operations and profitability.
In the future,
we may seek to enter into credit facilities to help fund our acquisition capital and working capital needs. These credit facilities may
expose us to additional risks associated with leverage and may inhibit our operating flexibility.
We may seek to enter
into credit facilities with third-party lenders to help fund our acquisitions. Such credit facilities will likely require us to pay a
commitment fee on the undrawn amount and will likely contain a number of affirmative and restrictive covenants. If we violate any such
covenants, our lenders could accelerate the maturity of any debt outstanding. Such debt may be secured by our assets, including the stock
we may own in businesses that we acquire. Our ability to meet our debt service obligations may be affected by events beyond our control
and will depend primarily upon cash produced by businesses that we currently manage and may acquire in the future and distributed or
paid to us. Any failure to comply with the terms of our indebtedness may have a material adverse effect on our financial condition.
In addition, we expect
that such credit facilities will bear interest at floating rates which will generally change as interest rates change. We will bear the
risk that the rates that we are charged by our lenders will increase faster than we can grow the cash flow from our businesses or businesses
that we may acquire in the future, which could reduce profitability, materially adversely affect our ability to service our debt, cause
us to breach covenants contained in our third-party credit facilities and reduce cash flow available for distribution.
30
If, in the future,
if we cease to control and operate our businesses or other businesses that we acquire in the future or engage in certain other activities,
we may be deemed to be an investment company under the Investment Company Act.
We have the ability
to make investments in businesses that we will not operate or control. If we make significant investments in businesses that we do not
operate or control, or that we cease to operate or control, or if we commence certain investment-related activities, we may be deemed
to be an investment company under the Investment Company Act. Our decision to sell a business will be based upon financial, operating
and other considerations rather than a plan to complete a sale of a business within any specific time frame. If we were deemed to be
an investment company, we would either have to register as an investment company under the Investment Company Act, obtain exemptive
relief from the Securities and Exchange Commission, or the SEC, or modify our investments or organizational structure or our contract
rights to fall outside the definition of an investment company. Registering as an investment company could, among other things, materially
adversely affect our financial condition, business and results of operations, materially limit our ability to borrow funds or engage
in other transactions involving leverage and require us to add directors who are independent of us and otherwise will subject us to additional
regulation that will be costly and time-consuming.
If intangible
assets and goodwill that we recorded in connection with our acquisitions become impaired, we may have to take significant charges against
earnings.
In connection with the
accounting for our completed acquisitions, we may be required to record a significant amount of intangible assets, including developed
technology, in-process research and development, and customer relationships relating to the acquired product lines, and goodwill. Under
generally accepted accounting principles in the United States, we must assess, at least annually and potentially more frequently, whether
the value of indefinite-lived intangible assets and goodwill have been impaired. Intangible assets and goodwill are assessed for impairment
in the event of an impairment indicator. Any reduction or impairment of the value of intangible assets and goodwill will result in a
charge against earnings, which could materially adversely affect our results of operations and shareholders’ equity in future periods.
Risks Relating to
Our Intellectual Property Rights
The failure to
obtain or maintain patents, licensing agreements and other intellectual property could materially impact our ability to compete effectively.
In order for our business
to be viable and to compete effectively, we need to develop and maintain, and we will heavily rely on, a proprietary position with respect
to our technologies and intellectual property. However, there are significant risks associated with our actual or proposed intellectual
property. The risks and uncertainties that we face with respect to our rights principally include the following:
● pending
patent applications we have filed or will file may not result in issued patents or may take longer than we expect to result in issued
patents;
● we
may be subject to interference proceedings;
● we
may be subject to reexamination proceedings;
●
we may be subject
to post grant review proceedings;
●
we may be subject
to inter partes review proceedings;
●
we may be subject
to derivation proceedings;
●
we may be subject
to opposition proceedings in the U.S. or in foreign countries;
●
any patents
that are issued to us may not provide meaningful protection;
●
we may not
be able to develop additional proprietary technologies that are patentable;
●
other companies
may challenge patents licensed or issued to us;
●
other companies
may have independently developed and patented (or may in the future independently develop and patent) similar or alternative technologies,
or duplicate our technologies;
31
●
other companies
may design around technologies we have licensed or developed;
●
enforcement
of patents is complex, uncertain and very expensive and we may not be able to secure, enforce and defend our patents; and
●
in the event
that we were to ever seek to enforce our patents in ligation, there is some risk that they could be deemed invalid, not infringed,
or unenforceable.
We cannot be certain
that any patents will be issued as a result of any pending or future applications, or that any patents, once issued, will provide us
with adequate protection from competing products. For example, issued patents may be circumvented or challenged, declared invalid or
unenforceable, or narrowed in scope. In addition, since publication of discoveries in scientific or patent literature often lags behind
actual discoveries, we cannot be certain that we or our licensors were the first to invent or to file patent applications covering them.
It is also possible
that others may have or may obtain issued patents that could prevent us from commercializing our products or require us to obtain licenses
requiring the payment of significant fees or royalties in order to enable us to conduct our business. There is no guarantee that such
licenses will be available based on commercially reasonable terms. As to those patents that we have licensed, our rights depend on maintaining
our obligations to the licensor under the applicable license agreement, and we may be unable to do so.
If we are unable
to obtain and maintain patent protection for our products, or if the scope of the patent protection obtained is not sufficiently broad,
competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our
products could be impaired.
The patent prosecution
process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications
at a reasonable cost, in a timely manner, or in all jurisdictions. It is also possible that we will fail to identify patentable aspects
of our development output before it is too late to obtain patent protection.
The patent position
of life science companies generally is highly uncertain, involves complex legal and factual questions and has in past years been the
subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the
United States, and we may fail to seek or obtain patent protection in all major markets. For example, unlike the U.S., European patent
law restricts the patentability of methods of treatment of the human body. Our pending and future patent applications may not result
in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing
competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and
other countries may diminish the value of our patents or narrow the scope of our patent protection, even post-grant.
Recent patent reform
legislation has increased the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense
of issued patents. On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith
Act includes a number of significant changes to United States patent law. These include provisions that affect the way patent applications
are prosecuted and may also affect patent litigation. The U.S. Patent and Trademark Office, or USPTO, recently developed new regulations
and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the
Leahy-Smith Act, and in particular, the first to file provisions, only became effective on March 16, 2013. Accordingly, it is not clear
what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation
could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our
issued patents, all of which could have a material adverse effect on our business and financial condition.
Moreover, we may be
subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter
partes review, post-grant review or interference proceedings challenging our patent rights (whether licensed or otherwise held)
or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of,
or invalidate, our patent rights (whether licensed or otherwise held), allow third parties to commercialize our technology or products
and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing
third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications (whether
licensed or otherwise held) is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize
current or future product candidates.
32
Even if our patent applications
(whether licensed or otherwise held) result in the issuance of patents, they may not issue in a form that will provide us with any meaningful
protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be
able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.
The issuance of a patent
is not conclusive as to its inventorship, scope, validity or enforceability, and our licensed or owned patents may be challenged in the
courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or
in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others
from using or commercializing similar or identical products, or limit the duration of the patent protection of our products. Given the
amount of time required for the development, testing and regulatory review of new life science product candidates, patents protecting
such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property rights
portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
We may become
involved in lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming and ultimately
unsuccessful.
Competitors may infringe
our intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be
expensive and time-consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against
us alleging that we infringe their intellectual property or that our intellectual property is invalid or unenforceable. In addition,
in a patent infringement proceeding, a court may decide that a licensed or owned patent of ours is invalid or unenforceable, in whole
or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds
that our patents do not cover that technology. Moreover, lawsuits to protect or enforce our intellectual property rights could be expensive,
time-consuming and ultimately unsuccessful.
Third parties
may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain.
Our commercial success
depends upon our ability to develop, manufacture, market and sell our product candidates without infringing the proprietary rights of
third parties. There is considerable intellectual property litigation in the life sciences industry. We cannot guarantee that our product
candidates will not infringe third-party patents or other proprietary rights. We may become party to, or threatened with, future adversarial
proceedings or litigation regarding intellectual property rights with respect to our products and technology, including inter
partes review, interference, or derivation proceedings before the USPTO and similar bodies in other countries. Third parties
may assert infringement claims against us based on existing intellectual property rights and intellectual property rights that may be
granted in the future.
If we are found to infringe
a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing
and marketing our products. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even
if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed
to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could
be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed
a patent. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business
operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets
of third parties could have a similar negative impact on our business.
Periodic maintenance
fees and annuities on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime
of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary,
fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured
by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result
in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure
to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal
documents. In such an event, our competitors might be able to enter our markets, which could have a material adverse effect on our business.
33
We may be subject
to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership
of what we regard as our own intellectual property.
Certain employees and
contractors were previously employed at universities or other companies, including potential competitors. Although we try to ensure that
our employees and contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to
claims that these employees or we have used or disclosed intellectual property, including trade secrets or other proprietary information,
of any such employee’s former employer. Litigation may be necessary to defend against these claims, and any such litigation could
have an unfavorable outcome.
In addition, while it
is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements
assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops
intellectual property that we regard as our own. Our and their assignment agreements may not be self-executing or may be breached, and
we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what
we regard as our intellectual property.
If we fail in prosecuting
or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.
Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and adverse results,
and be a distraction to management.
Some intellectual
property which we own or have licensed may have been discovered through government funded programs such as, for example, the government
funded programs referenced in intellectual property licensed under the LLU License Agreement, and thus may be subject to federal regulations
such as “march-in” rights, certain reporting requirements, and a preference for United States industry. Compliance with such
regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements, and limit
our ability to contract with non-U.S. manufacturers.
Some of the intellectual
property rights we own or have licensed have been generated through the use of United States government funding and may therefore be
subject to certain federal regulations. As a result, the United States government may have certain rights to intellectual property embodied
in our current or future products and product candidates pursuant to the Bayh-Dole Act of 1980. These United States government rights
in certain inventions developed under a government-funded program include a non-exclusive, non-transferable, irrevocable worldwide license
to use inventions for any governmental purpose. In addition, the United States government has the right to require us to grant exclusive,
partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (i) adequate steps
have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or
(iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in
rights”). The United States government also has the right to take title to these inventions if we fail to disclose the invention
to the government and fail to file an application to register the intellectual property within specified time limits. In addition, the
United States government may acquire title to these inventions in any country in which a patent application is not filed within specified
time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance
with which may require us to expend substantial resources. In addition, the United States government requires that any products embodying
the subject invention or produced through the use of the subject invention be manufactured substantially in the United States. The manufacturing
preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have
been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States
or that under the circumstances domestic manufacture is not commercially feasible. This preference for United States manufacturers may
limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property. Any exercise by
the government of any of the foregoing rights could harm our competitive position, business, financial condition, results of operations
and prospects.
We rely on information
technology, and if we are unable to protect against service interruptions, data corruption, cyber-based attacks or network security breaches,
our operations could be disrupted, and our business could be negatively affected.
We rely on information
technology networks and systems to process, transmit and store electronic and financial information; to coordinate our business; and
to communicate within our Company and with customers, suppliers, partners and other third-parties. These information technology systems
may be susceptible to damage, disruptions or shutdowns, hardware or software failures, power outages, computer viruses, cyber-attacks,
telecommunication failures, user errors or catastrophic events. If our information technology systems suffer severe damage, disruption
or shutdown, and our business continuity plans do not effectively resolve the issues in a timely manner, our operations could be disrupted,
and our business could be negatively affected. In addition, cyber-attacks could lead to potential unauthorized access and disclosure
of confidential information, and data loss and corruption. There is no assurance that we will not experience these service interruptions
or cyber-attacks in the future.
34
Risks Relating to
the Litigation and Government Regulation
Claims, litigation,
government investigations, product liability and recalls, and other proceedings may adversely affect our business, operating results,
financial condition, and cash flows.
We are, from time to
time, involved in various claims, litigation matters and regulatory proceedings that could have a material adverse effect on us. These
matters may include personal injury and other tort claims, deceptive trade practice disputes, intellectual property disputes, product
recalls, contract disputes, employment and tax matters and other proceedings and litigation, including class actions lawsuits. It is
not possible to predict the outcome of pending or future litigation and any such claims, with or without merit, could be time consuming
and expensive, and may require the Company to incur substantial costs and divert the resources of management.
On February 3, 2026,
Vertalo, Inc. filed an Original Petition against Aditxt, Inc. in the District Court of Travis County, Texas (98th Judicial District),
Cause No. D-1-GN-26-000795. The complaint asserts claims for breach of contract and seeks, among other relief, alleged unpaid fees of
$300,000, warrants to acquire 6,250 shares of Aditxt common stock, $26,000 of alleged travel-related costs, additional alleged damages
of at least $500,000, attorneys’ fees, and interest. Aditxt disputes the allegations and intends to defend the matter vigorously,
pursue counterclaims and pursue available claims and defenses. Based on information available to the Company at present, the Company
cannot reasonably estimate a range of loss for this potential action We cannot predict the outcome of this dispute with certainty. Regardless
of the outcome, these can have an adverse impact on us because of legal costs, diversion of management resources and other factors.
Determining legal reserves
or possible losses from claims against us involves judgment and may not reflect the full range of uncertainties and unpredictable outcomes.
Until the final resolution of such matters, we may be exposed to losses in excess of the amount recorded, and such excess amounts could
have a material effect on our business, results of operations, financial condition, and cash flows. In addition, it is possible that
a resolution of any claim, including as a result of a settlement, could require us to make substantial future payments, prevent us from
offering certain products or services, or require us to change our business practices each of which could have a material adverse effect
on our business, operating results, financial condition, and cash flows.
We must successfully
manage compliance with current and expanding laws and regulations, as well as manage new and pending legal and regulatory matters in
the U.S. and abroad.
We are subject in the
ordinary course of our business, in the U.S. and internationally, to many statutes, ordinances, rules and regulations that, if violated
by us or the third parties we work with, could have a material adverse effect on our business, operating results, financial condition,
and cash flows. These laws and regulations include but are not limited to accounting and financial reporting, advertising, anti-bribery
and anti-corruption, consumer protection, data security and privacy, electronic commerce, employment, intellectual property, product
liability, and trade. In addition, increasing governmental and societal attention to environmental, social and governance (ESG) matters,
including expanding mandatory and voluntary reporting, diligence and disclosure on topics such as climate change, waste production, water
usage, human capital, labor and risk oversight, could expand the nature, scope and complexity of matters that we are required to control,
assess and report, each of which can be challenging given our reliance on third party suppliers. These and other rapidly changing laws,
regulations, policies and related interpretations as well as increased enforcement actions by various governmental and regulatory agencies,
create challenges for us, including our compliance and ethics programs, may alter the environment in which we do business and may increase
the ongoing costs of compliance, which could adversely impact our business, operating results, financial condition, and cash flows. If
we are unable to continue to meet these challenges and to comply with all laws, regulations, policies and related interpretations, it
could negatively impact our reputation and our business, operating results, financial condition, and cash flows. Additionally, we may
in the future be subject to inquiries, investigations, claims, proceedings and requests for information from governmental agencies or
private parties, the adverse outcomes of which could harm our business. Failure to successfully manage these new or pending regulatory
and legal matters and to resolve such matters without significant liability or damage to our reputation may materially adversely impact
our operating results, financial condition, and cash flows. Furthermore, if new legal or regulatory matters result in fines or costs
in excess of the amounts accrued to date, that may also materially impact our operating results and financial position.
Risks Related to
Our Common Stock
We do not expect
to pay dividends in the foreseeable future.
We do not intend to
declare dividends for the foreseeable future, as we anticipate that we will reinvest any and all future earnings in the development and
growth of our business. Therefore, investors will not receive any funds unless they sell their securities, and holders may be unable
to sell their securities on favorable terms or at all. We cannot assure you of a positive return on your investment or that you will
not lose the entire amount of your investment.
35
Future sales or
issuances of substantial amounts of our common stock, including, potentially, as a result of the future acquisitions or strategic transactions
could result in significant dilution.
If additional shares
are issued in connection with the proposed acquisition transactions or additional capital is raised through the sale of equity or convertible
debt securities, the issuance of those securities could result in further dilution to our stockholders.
We may engage
in future acquisitions or strategic transactions, which may require us to seek additional financing or financial commitments, increase
our expenses and/or present significant distractions to our management.
Obtaining financing
for future acquisitions may only be possible through the issuance or sale of additional equity and/or debt securities, if possible, may
not be at favorable terms and may result in additional dilution to our current stockholders. Additionally, any such transactions may
require us to incur non-recurring or other charges, may increase our near and long-term expenditures and may pose significant integration
challenges or disrupt our management or business, which could adversely affect our operations and financial results. For example, an
acquisition or strategic transaction may entail numerous operational and financial risks, including the risks outlined above and additionally:
●
exposure to
unknown liabilities;
●
disruption
of our business and diversion of our management’s time and attention in order to develop acquired products or technologies;
●
higher than
expected acquisition and integration costs;
●
write-downs
of assets or goodwill or impairment charges;
●
increased amortization
expenses;
●
difficulty
and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
●
impairment
of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and
●
inability to
retain key employees of any acquired businesses.
Accordingly, although
there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, and any transactions
that we do complete could have a material adverse effect on our business, results of operations, financial condition and prospects.
Upon dissolution
of our Company, you may not recoup all or any portion of your investment.
In the event of a liquidation,
dissolution or winding-up of our Company, whether voluntary or involuntary, our assets would be used to pay all of our debts and liabilities,
and only thereafter would any remaining assets be distributed to our stockholders, subject to rights of the holders of the Preferred
Stock, if any, on a pro rata basis. There can be no assurance that we will have assets available from which to pay any
amounts to our stockholders upon such a liquidation, dissolution or winding-up. In such an event, you would lose all of your investment.
Anti-takeover
provisions under Delaware law could discourage, delay or prevent a change in control of our Company and could affect the trading price
of our securities.
We are a Delaware corporation
and the anti-takeover provisions of the Delaware General Corporation Law may discourage, delay or prevent a change in control by prohibiting
us from engaging in a business combination with an interested stockholder for a period of three years after the person becomes an interested
stockholder, even if a change in control would be beneficial to our existing stockholders.
36
We could issue
“blank check” preferred stock without stockholder approval with the effect of diluting interests of then-current
stockholders and impairing their voting rights, and provisions in our charter documents and under Delaware law could discourage a takeover
that stockholders may consider favorable.
Our Amended and Restated
Certificate of Incorporation provides for the authorization to issue up to 3,000,000 shares of “blank check” preferred
stock with designations, rights and preferences as may be determined from time to time by our board of directors. Our board of directors
is empowered, without stockholder approval, to issue one or more series of preferred stock with dividend, liquidation, conversion, voting
or other rights which could dilute the interest of, or impair the voting power of, our common stockholders. The issuance of a series
of preferred stock could be used as a method of discouraging, delaying or preventing a change in control. For example, it would be possible
for our board of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt
to change control of our company. In addition, advanced notice is required prior to stockholder proposals, which might further delay
a change of control.
Our Amended and
Restated Certificate of Incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for
substantially all disputes between the Company and its stockholders, which could limit stockholders’ ability to obtain a favorable
judicial forum for disputes with the Company or its directors, officers or employees.
Our Amended and Restated
Certificate of Incorporation provides that unless the Company consents in writing to the selection of an alternative forum, the State
of Delaware is the sole and exclusive forum for: (i) any derivative action or proceeding brought on behalf of the Company, (ii)
any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of the Company to the Company
or the Company’s stockholders, (iii) any action asserting a claim against the Company, its directors, officers or employees arising
pursuant to any provision of the Delaware General Corporation Law (the “DGCL”) or our Amended and Restated Certificate
of Incorporation or the Company’s Amended and Restated Bylaws, or (iv) any action asserting a claim against the Company, its directors,
officers, employees or agents governed by the internal affairs doctrine, except for, as to each of (i) through (iv) above, any claim
as to which the Court of Chancery determines that there is an indispensable party not subject to the jurisdiction of the Court of Chancery
(and the indispensable party does not consent to the personal jurisdiction of the Court of Chancery within ten days following such determination),
which is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery, or for which the Court of Chancery
does not have subject matter jurisdiction. This exclusive forum provision would not apply to suits brought to enforce any liability or
duty created by the Securities Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. To
the extent that any such claims may be based upon federal law claims, Section 27 of the Exchange Act creates exclusive federal jurisdiction
over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder.
Section 22 of the Securities
Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the
Securities Act or the rules and regulations thereunder. However, our Amended and Restated Bylaws contain a federal forum provision which
provides that unless the Company consents in writing to the selection of an alternative forum, the federal district courts of the United
States of America will be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities
Act. Any person or entity purchasing or otherwise acquiring any interest in shares of capital stock of the Corporation are deemed to
have notice of and consented to this provision. The Supreme Court of Delaware has held that this type of exclusive federal forum provision
is enforceable. There may be uncertainty, however, as to whether courts of other jurisdictions would enforce such a provision, if applicable.
These choice of forum
provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the
Company or its directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and
other employees. Alternatively, if a court were to find our choice of forum provisions contained in either our Amended and Restated Certificate
of Incorporation or Amended and Restated Bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated
with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition.
We no longer qualify
as an “emerging growth company” as of January 1, 2026 and, as a result, we are no longer able to avail ourselves of certain
reduced disclosure requirements applicable to emerging growth companies.
As of January 1, 2026
we no longer qualify as an emerging growth company within the meaning of Section 2(a) of the Securities Act, as modified by the JOBS
Act. As such, we are subject to certain disclosure and compliance requirements that apply to other public companies but did not previously
apply to us due to our status as an emerging growth company.
37
We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may
make it more difficult to compare our performance with other public companies and make our common stock less attractive to investors.
We are a “smaller
reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced
disclosure obligations, including, among other things, providing only two years of audited consolidated financial statements. We will
remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common stock held by nonaffiliates
exceeds $250 million as of the prior June 30 or (ii) our annual revenues exceeded $100 million during such completed fiscal year and
the market value of our common stock held by non affiliates exceeds $700 million as of the prior June 30. To the extent we take advantage
of such reduced disclosure obligations, it may also make comparisons of our consolidated financial statement with other public companies
difficult or impossible.
Item 1B. Unresolved
Staff Comments.
Not applicable.
Item 1C. Cybersecurity.
Cybersecurity is important
to our operations and technological development efforts. We face a multitude of cybersecurity threats that range from attacks common
to most industries, such as ransomware and denial-of-service. Our customers, suppliers, subcontractors, and business partners face similar
cybersecurity threats, and a cybersecurity incident impacting us or any of these entities could materially adversely affect our business
strategy, performance, and results of operations. These cybersecurity threats and related risks make it imperative that we expend resources
on cybersecurity.
We have processes in
place for assessing, identifying, and managing material risks from potential unauthorized occurrences on or through our information systems
that could adversely affect the confidentiality, integrity, or availability of our information systems or the information residing on
those systems. These include mechanisms, controls, and processes that are designed to prevent, detect, or mitigate data loss, theft,
misuse, unauthorized access, or other security incidents or vulnerabilities affecting the data. The data includes confidential, proprietary,
and business and personal information that we collect, process, store, and transmit as part of our business, including on behalf of third
parties . We consider cybersecurity risks associated with third-party vendors and service providers as part of our overall risk management
processes and may assess such vendors’ security practices where appropriate.
We maintain a cybersecurity
risk management program operating under our Information Security & Risk Management Strategy (“ISRM”). This program is
responsible for implementing and maintaining cybersecurity and data protection practices at Aditxt in close coordination with management
and other teams across Aditxt. In addition to our in-house cybersecurity capabilities, we may engage assessors, consultants, auditors,
or other third parties to assist with assessing, identifying, and managing cybersecurity risks . Management evaluates cybersecurity risks
and associated mitigation efforts. As of the date of this report, the Company is not aware of any material risks from cybersecurity threats
that have materially affected or are reasonably likely to materially affect the Company, including its business strategy, results of
operations, or financial condition. Despite the measures we take to manage cybersecurity risk, we may not be successful in preventing
or mitigating a cybersecurity incident that could have a material adverse effect on the Company or its stakeholders.
The Audit Committee
oversees the Company’s cybersecurity risk management, including oversight of the Company’s Information Security & Risk
Management Strategy (“ISRM”). The ISRM establishes a governance framework for cybersecurity oversight and designates an ISRM
Leadership Group responsible for implementing and maintaining the Company’s cybersecurity and data protection practices. Management
reports to the Audit Committee regarding cybersecurity risks and significant cybersecurity incidents.
38
Risk
Management
We evaluate our security
controls through internal assessments and may engage third-party services to support penetration testing, independent reviews, or consulting
on best practices. We have established cybersecurity awareness training and ongoing monitoring.
In the event of a cybersecurity
incident, we follow established procedures to respond to and mitigate its impact, including coordination among internal personnel, use
of external service providers where appropriate, and implementation of disaster recovery procedures. We may engage external firms with
information technology and program management experience to assist in evaluating or managing cybersecurity risks. We have implemented
a governance structure and processes to assess, identify, manage, and report cybersecurity risks. We must comply with extensive regulations,
including requirements imposed by the U.S. Food and Drug Administration, laws governing the protection of patient information, and SEC
requirements related to cybersecurity incident disclosure. Assessing, identifying, and managing cybersecurity-related risks are factored
into our overall business approach. We rely heavily on our supply chain to deliver our products and services, and a cybersecurity incident
at a clinical site, subcontractor, or business partner could materially adversely impact us. We expect our subcontractors to report cybersecurity
incidents to us so that we can assess the potential impact.
Governance
The Audit Committee
has oversight responsibility for risks and incidents relating to cybersecurity threats, including compliance with disclosure requirements,
cooperation with law enforcement, and related effects on financial and other risks, and it reports any findings and recommendations,
as appropriate, to the full board of directors for consideration . Management provides periodic reports to the Audit Committee regarding
cybersecurity risks and trends and any material cybersecurity incidents.
While we have not experienced
any material cybersecurity threats or incidents in recent years, there can be no guarantee that we will not be the subject of future
threats or incidents. Despite the measures we take to manage cybersecurity risk, we may not be successful in preventing or mitigating
a cybersecurity incident that could have a material adverse effect on us. While we maintain cybersecurity insurance, the costs related
to cybersecurity threats or disruptions may not be fully insured. See “Risk Factors” for a discussion of cybersecurity risks.
Item 2. Properties.
We lease property consisting
of office and laboratory space located at 2569 Wyandotte, St., Suite 101 Mountain View, CA 94043. On March 20, 2025, the Company entered
an amendment to the Mountain View lease, extending the term through March 31, 2028. As of December 31, 2025 the Company is current on
our Mountain View lease.
We lease property consisting
of office and laboratory space located at 737 N. 5 th Street Richmond, Virginia 23219. The lease expires on August 31,
2026, subject to extension. As of December 31, 2025 the Company is in default on the lease in the amount of $159,375 due to an outstanding
security deposit.
Item 3. Legal Proceedings.
From time to time, we
may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. However, litigation is
subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business.
The Company does not
believe that the final outcome of any current legal proceedings will have a material adverse effect on the Company’s financial
position or results of operations. In addition, the Company maintains what it believes is adequate insurance coverage to further mitigate
risk. However, no assurance can be given that the final outcome of any such proceedings will not materially impact the Company’s
financial condition or results of operations. Further, no assurance can be given that the amount or scope of existing insurance coverage
will be sufficient to cover losses arising from any such matters.
Item 4. Mine Safety
Disclosures.
Not applicable.
39
PART II
Item 5. Market for
Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information
On June 30, 2020, our
common stock began trading on the Nasdaq Capital Market under the symbol “ADTX.” Prior to that time, there was no public
market for our common stock.
Holders
As of March 31, 2026, there were approximately 174 record holders
of our common stock. As of March 31, 2026, there were 6, 2, 5, 1, and 2 holder(s) of Series A-1 Convertible Preferred Stock, Series A-2
Convertible Preferred Stock, Series B-1 Convertible Preferred Stock, Series B-2 Convertible Preferred Stock, and Series C-1 Convertible
Preferred Stock respectively. The actual number of holders of our common stock is greater than this number of record holders, and includes
stockholders who are beneficial owners, but whose shares are held in street name by brokers or held by other nominees.
Dividend Policy
We have never paid or
declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable
future. We intend to retain all available funds and any future earnings to fund the development and expansion of our business. Any future
determination to pay dividends will be at the discretion of our board of directors and will depend upon a number of factors, including
our results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and
other factors that our board of directors deems relevant.
Recent Sales of Unregistered
Securities
On
June 24, 2025, the Company issued a consultant 664 common stock warrants to purchase 664 shares of common stock for services rendered.
Equity Compensation
Plans
The information required
by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 12 of Part III
of this Annual Report on Form 10-K.
Issuer Purchases
of Equity Securities
We did not purchase
any of our registered equity securities during the period covered by this Annual Report.
Item 6. [Reserved]
Not applicable.
40
Item 7. Management’s
Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion
and analysis of our financial condition and results of operations should be read together with our financial statements and the related
notes and other financial information included elsewhere in this report. Some of the information contained in this discussion and analysis
or set forth elsewhere in this report, including information with respect to our plans and strategy for our business, includes forward-looking
statements that involve risks and uncertainties. See “Cautionary Note Regarding Forward-Looking Statements.”
Overview and Mission
We believe the world
needs—and deserves—a new approach to innovating that harnesses the power of large groups of stakeholders who work together
to ensure that the most promising innovations make it into the hands of people who need them most.
We were incorporated
in the State of Delaware on September 28, 2017, and our headquarters are in Mountain View, California. The company was founded with a
mission of bringing stakeholders together, to transform promising innovations into products and services that could address some of the
most challenging needs. The socialization of innovation through engaging stakeholders in every aspect of it, is key to transforming more
innovations, more rapidly, and more efficiently.
At inception, the first
innovation we took on was an immune modulation technology titled ADI/Adimune with a focus on prolonging life and enhancing life quality
of patients that have undergone organ transplants. Since then, we expanded our portfolio of innovations, and we continue to evaluate
a variety of promising health innovations.
ADIMUNE ™ ,
INC. - Subsidiary
Formed in January 2023,
Adimune™, Inc. (“Adimune”) is focused on leading our immune modulation therapeutic programs. Adimune’s proprietary
immune modulation product, Apoptotic DNA Immunotherapy™ (ADI™), utilizes a novel approach that mimics the way our bodies
naturally induce tolerance to our own tissues. It includes two DNA molecules designed to deliver signals to induce tolerance. ADI-100,
the first product candidate based on the ADI platform, is designed to tolerize against an antigen known as glutamic acid decarboxylase
(“GAD”), which is implicated in type-1 diabetes (T1D), psoriasis, and in many autoimmune diseases of the CNS and has been
successfully tested in several preclinical models (e.g., skin grafting, psoriasis, and T1D).
All preclinical studies
for ADI-100 have been completed providing several data points supporting the potential effectiveness of ADI-100 in restoring durable
tolerance as shown in prevention and treatment studies in T1D. Preclinical safety and toxicology studies have shown absence of drug toxicity,
no antibody formation to the drug product, and a lack of persistence in all organs evaluated except the skin (at the injection site).
Furthermore, Adimune has demonstrated in three separate preclinical studies that ADI-100 does not impair the responsiveness of the immune
system to combat infection, cancer, or the tumor fighting capabilities of checkpoint inhibitors.
Good Manufacturing Practices
(GMP) clinical-grade drug substances have been successfully manufactured by a qualified contract manufacturer. The clinical grade drug
substances are now being prepared for shipment to another contract manufacturer to be formulated into the final drug product in preparation
for stability testing and use in the clinical trials pending required regulatory submissions. Lastly, one remaining drug product release
assay specifically designed for ADI-100 is in the final stages of qualification to be used once the final drug product is ready.
Preclinical and manufacturing
data, including the clinical-grade drug substance, are essential components of the complete dossier that we intend to submit to the regulatory
agencies, which evaluate the safety and quality of the final drug product to be administered in the clinical trials. Adimune has had
pre-submission meetings with the regulatory agency in Germany and has completed the additional studies requested.
For the clinical trials
that are planned in Germany, Adimune has engaged with a Contract Research Organization (CRO) to manage the process, including site selection
for clinical studies planned in psoriasis and T1D. In parallel, Adimune is working with the Mayo Clinic to prepare the IND package for
FDA submission and is awaiting a pre-IND meeting expected in the second quarter of this year to review the package before full submission.
In May 2023, Adimune entered into a clinical trial agreement with the Mayo Clinic to advance clinical studies targeting autoimmune diseases
of the central nervous system (“CNS”) with the initial focus on the rare, but debilitating, autoimmune disease Stiff Person
Syndrome (“SPS”). According to the National Organization of Rare Diseases, the exact incidence and prevalence of SPS is unknown;
however, one estimate places the incidence at approximately one in one million individuals in the general population. Pending approval
by the International Review Board and U.S. Food and Drug Administration, a human trial for SPS is expected to get underway in 2026 with
enrollment of 10-20 patients, some of whom may also have T1D. In these studies, the primary readouts for ADI-100 will be safety and tolerability
as well as clinical and immunological signals of tolerance induction.
41
Background
The discovery of immunosuppressive
(anti-rejection and monoclonal) drugs over 40 years ago has made possible treatment of autoimmune diseases and life-saving organ transplantation
procedures and blocking of unwanted immune responses in autoimmune diseases. However, immune suppression leads to significant undesirable
side effects, such as increased susceptibility to life-threatening infections and cancers, because it indiscriminately and broadly suppresses
immune function throughout the body. While the use of these drugs has been justifiable because they prevent or delay organ rejection,
their use for treatment of autoimmune diseases and allergies may not be acceptable because of the aforementioned side effects. Furthermore,
often transplanted organs ultimately fail despite the use of immune suppression, and about 40% of transplanted organs survive no more
than five years.
Through Aditxt, Adimune
has the right to the exclusive worldwide license for commercializing ADI nucleic acid-based technology from Loma Linda University. ADI
uses a novel approach that mimics the way the body naturally induces tolerance to our own tissues (“therapeutically induced immune
tolerance”). While immune suppression requires continuous administration to prevent rejection of a transplanted organ, induction
of tolerance has the potential to retrain the immune system to accept the organ for longer periods of time. ADI may allow patients to
live with transplanted organs with significantly reduced immune suppression. ADI is a technology platform which we believe can be engineered
to address a wide variety of indications.
Advantages
ADI™ is a nucleic
acid-based technology ( e.g. , DNA-based), which we believe selectively suppresses only those immune cells involved in attacking
(in autoimmune diseases) or rejecting self (in transplanted tissues and organs). It does so by tapping into the body’s natural
process of cell turnover (i.e., apoptosis) to retrain the immune system to stop unwanted attacks on self or transplanted tissues. Apoptosis
is a natural process used by the body to clear dying cells and to allow recognition and tolerance to self-tissues. ADI triggers this
process by enabling the cells of the immune system to recognize the targeted tissues as “self.” Conceptually, it is designed
to retrain the immune system to accept the tissues, similar to how natural apoptosis reminds our immune system to be tolerant to our
own “self” tissues.
While various groups
have promoted tolerance through cell therapies and ex vivo manipulation of patient cells (i.e., takes place outside
the body), to our knowledge, we will be unique in our approach of using in-body induction of apoptosis to promote tolerance to specific
tissues. In addition, ADI treatment itself will not require additional hospitalization but only an injection of minute amounts of
the therapeutic drug into the skin.
Moreover, preclinical
studies have demonstrated that ADI treatment significantly and substantially prolongs graft survival, in addition to successfully “reversing”
other established immune-mediated inflammatory processes.
License Agreement
with Loma Linda University (“LLU”)
On March 15, 2018, we
entered into a License Agreement with LLU, which was subsequently amended on July 1, 2020. Pursuant to the LLU License Agreement, we
obtained the exclusive royalty-bearing worldwide license to all intellectual property, including patents, technical information, trade
secrets, proprietary rights, technology, know-how, data, formulas, drawings, and specifications, owned or controlled by LLU and/or any
of its affiliates (the “LLU Patent and Technology Rights”) and related to therapy for immune-mediated inflammatory diseases
(the ADI™ technology). In consideration for the LLU License Agreement, we issued 1 shares of common stock to LLU.
PEARSANTA, INC.
Subsidiary
The best approach to
addressing cancer may be its early detection. Pearsanta is pioneering the development of molecular tests based on the mitochondrial DNA
to develop tests for early detection of cancer. Though further technical development and clinical validation is required to determine
efficacy in multiple diseases and disease states, our management believes that the unique structural and functional characteristics of
mitochondrial DNA (mtDNA), and more specifically mutated mtDNA, make mtDNA a biological system suitable for biomarker identification,
early disease detection, monitoring, risk assessment, and therapeutic targeting.
42
Pearsanta acquired the
assets of MDNA Life Sciences Inc. on January 4, 2024. Through the acquisition of these assets, and in particular the Mitomic ®
Technology platform, patents, and intellectual property, our management believes that Pearsanta is well positioned for research and discovery
of mtDNA based biomarkers, and though untested and requiring clinical validation, the development and commercial application of mtDNA
based biomarkers for a wide spectrum of human diseases.
Pearsanta is continuing
to leverage this technology to discover mtDNA-based biomarkers. Though Pearsanta has no commercially available FDA or foreign regulator
approved products, Pearsanta has two product candidates in development and hopes to enter the cancer screening market with these two
product candidates, and if proven successful continue to discover mtDNA-based biomarkers and develop a pipeline of disease screening
and diagnostics tests. The current in-development products include a potential product for prostate cancer diagnosis and a potential
product for the detection of endometriosis. Pearsanta has also discovered mtDNA-based biomarkers, which it believes are associated with
ovarian cancer and lung cancer; and Pearsanta intends to pursue the biomarker identification phase of development for pancreatic, liver,
breast, stomach, esophageal, and colorectal cancers.
Licensed Technologies
– AditxtScore TM
We issued Pearsanta an exclusive worldwide sub-license (the “Exclusive Worldwide Sublicense Agreement”) for commercializing
the AditxtScore™ technology which provides a personalized comprehensive profile of the immune system. AditxtScore is intended to
detect individual immune responses to viruses, bacteria, peptides, drugs, supplements, bone marrow and solid organ transplants, and cancer.
It has broad applicability to many other agents of clinical interest impacting the immune system, including those not yet identified such
as emerging infectious agents. On September 23, 2025, the Company and Pearsanta entered in a Mutual Termination Agreement (the “Exclusive
Worldwide Sublicense Termination Agreement”) to terminate the Exclusive Worldwide Sublicense Agreement. As provided in the Exclusive
Worldwide Sublicense Termination Agreement, the Exclusive Worldwide Sublicense Agreement has been terminated in its entirety and all rights
and obligations of the parties under the Exclusive Worldwide Sublicense Agreement have ceased. A non-exclusive licensing agreement has
been granted by Aditxt to Pearsanta as of December 30, 2025 for the use of the technology for evaluating levels of antibodies and neutralizing
antibodies to SARS-CoV-2, which are currently available in use by the CLIA/CAP facility in Richmond, VA.
Advantages
The advantages of the
AditxtScore technology include the following:
● greater
sensitivity/specificity.
● 20-fold
higher dynamic range, greatly reducing signal to noise compared to conventional assays.
● ability
to customize assays and multiplex a large number of analytes with speed and efficiency.
● ability
to test for cellular immune responses (i.e., T and B cells and cytokines).
● proprietary
reporting algorithm.
License Agreement
with Leland Stanford Junior University (“Stanford”)
On February 3, 2020,
we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford with regard to a patent
concerning a method for detection and measurement of specific cellular responses. Pursuant to the February 2020 License Agreement, we
received an exclusive worldwide license to Stanford’s patent with regard to use, import, offer, and sale of Licensed Products (as
defined in the agreement). The license to the patented FlowSpot technology is exclusive, including the right to sublicense, beginning
on the effective date of the agreement, and ending when the patent expires. Under the exclusivity agreement, we acknowledged that Stanford
had already granted a non-exclusive license in the Nonexclusive Field of Use, under the Licensed Patents in the Licensed Field of Use
in the Licensed Territory (as those terms are defined in the “February 2020 License Agreement”). However, Stanford agreed
not to grant further licenses under the Licensed Patents in the Licensed Field of Use in the Licensed Territory. On December 29, 2021,
we entered into an amendment to the February 2020 License Agreement which extended our exclusive right to license the technology and
securing worldwide exclusivity in all fields of use of the licensed technology.
43
AditxtScore has been
designed to enable individuals and their healthcare providers to understand, manage and monitor their immune profiles and to stay informed
about attacks on or by their immune system. We believe AditxtScore can also assist the medical community and individuals by being able
to anticipate the immune system’s potential response to viruses, bacteria, allergens, and foreign tissues such as transplanted
organs. This technology may be able to serve as a warning signal, thereby allowing for more time to respond appropriately. Its advantages
include the ability to provide simple, rapid, accurate, high throughput assays that can be multiplexed to determine the immune status
with respect to several factors simultaneously, in approximately 3-16 hours. In addition, it can determine and differentiate between
distinct types of cellular and humoral immune responses (e.g., T and B cells and other cell types). It also provides for simultaneous
monitoring of cell activation and levels of cytokine release (i.e., cytokine storms).
In collaboration with
its partners, the platforms underlying AditxtScore are being further evaluated for evaluating the immune status of individuals including
those with hypersensitivity to certain antigens (e.g., patients with autoimmunity). These tests may become tools that can monitor dynamic
changes after administration of immunotherapies designed to tolerize to these target antigens.
Technologies
– Mitomic ® Technology Platform
In January 2024, Pearsanta
acquired the assets comprising our Mitomic ® Technology platform from MDNA Life Sciences Inc. This platform seeks
to harness the unique properties of mitochondrial DNA (“mtDNA”) to detect disease through non-invasive, blood-based liquid
biopsies. Though further technical development and clinical validation is required to determine efficacy in multiple diseases and disease
states, our management believes that the unique structural and functional characteristics of mtDNA, and more specifically mutated mtDNA,
make mtDNA a biological system suitable for biomarker identification, early disease detection, monitoring, risk assessment, and therapeutic
targeting.
Pearsanta plans to license
distribution rights through various agreements with U.S.-based and international business partners to commercialize our Mitomic ®
Technology, should Mitomic ® tests be successfully developed and successfully approved by the FDA or a foreign regulator
or other relevant regulatory body. We believe our biomarker portfolio covers many high-clinical need cancers, with potential applications
outside oncology.
Pearsanta a state-of-the-art
facility located in Richmond VA, that is a high-complexity, CLIA-certified, CAP-accredited and NYS CLEP-approved accredited laboratory
equipped to accommodate rapid development and rollout of innovative laboratory tests for the clinical market. Our laboratory facility
is optimized for contamination prevention including dedicated workspaces for key functions; advanced molecular biology capabilities including
digital PCR, real-time PCR, automated electrophoresis with scale-up capacity and redundancy; and automated and semi-automated (robotic)
processes for DNA/RNA isolation and liquid handling to achieve efficient and standardized workflows.
Our Mitomic ®
Products and Product Candidates
The Mitomic ®
Technology targets mutations in mitochondrial DNA (mtDNA) to detect disease. Every human cell is home to multiple copies of
mitochondrial mtDNA, some of which become mutated beyond repair when cells are stressed by diseases such as cancer. Though further technical
development and clinical validation is required to determine efficacy, Mitomic ® tests are being designed to detect
this mutated DNA, which can accumulate from the very early stages of a disease. If the development of Mitomic ®
tests is successful and if Mitomic ® tests can achieve their still unproven objective of early disease detection,
our Mitomic ® Technology presents an opportunity to detect disease before it presents clinically.
The Mitomic ®
Technology platform is designed to identify biomarker targets, develop robust assays, discover new biomarkers, and develop new products.
The biomarker identification program is based on the identification of a new class of molecules generated through a process associated
with mitochondria. The Mitomic ® Technology platform has already discovered biomarkers which are believed to be
associated with cancer and has generated an “in-silico” database, which is an experiment that generates thousands of potential
biomarkers, developed through computer software and simulation.
44
To date, the Mitomic ®
Technology biomarker discoveries have identified numerous biomarker targets from the in-silico database and we plan to use these biomarker
targets in our various assay development programs.
Mitomic ®
Prostate Test (MPT™) is currently in development and is being designed as a blood-based assay that quantifies the level
of the 3.4kb mtDNA deletion. Published analytical data for the 3.4kb mtDNA deletion associated with prostate cancer, suggests the 3.4kb
mtDNA deletion may be able to identify clinically significant prostate cancer for men in the prostate-specific antigen (PSA) grey zone
(PSA < 10ng/ml) and if proven through ongoing clinical study, the 3.4kb mtDNA deletion may be able to aid in the decision to biopsy.
Some of the significant clinical challenges that have not been met for prostate cancer are that up to 50% of men will be ‘over’
diagnosed with cancer that never harms them 1 and the risks associated with treatment of low-grade cancers (≤ Gleason
6) appear to outweigh the benefits –e.g. urinary incontinence, erectile dysfunction. 1 NIH National Cancer Institute
reports this number is even higher at ~ 75% based on 5-year survival rates. Seer database (https://seer.cancer.gov/statfacts/html/prost.html).
Our
Mitomic ® Prostate Test is in development and is being designed with the following objectives:
● Simple
– The test is expected to be completed using a patient’s blood sample and is not expected to require an algorithm.
● Provide
New Information – If ongoing clinical studies support the published analytical data for the 3.4kb mtDNA deletion, healthcare providers
will be provided with new information related to clinically significant prostate cancer – independent of PSA, age, and family history.
Mitomic Endometriosis
Test (MET™) is currently in development and is being designed as a blood-based assay that quantifies the level of one
or more mtDNA deletions which published analytical data suggest are associated with endometriosis – a condition affecting approximately
1 in 10 women according to Endometriosis World and the World Health Organization. The Mitomic Endometriosis Test is intended for use
in females of child-bearing age who present symptoms of endometriosis to determine whether medical or surgical intervention is warranted.
Endometriosis occurs
when the tissue of the uterus (endometrium) grows in areas where it does not belong, most often on the ovaries, fallopian tubes, outer
surface of the uterus, and tissues holding the uterus, but can be found almost anywhere in the body. Endometriosis is challenging to
identify, and on average takes ten years to diagnose, and when patients are finally diagnosed, greater than 90% have moderate to severe
symptoms.
Technologies –
Adductomics Technology
On March 21, 2025,
Pearsanta acquired certain patents related to the detection and analysis of DNA adducts. DNA adducts are chemically modified nucleotides
that result from exposure to carcinogens and other damaging agents, serving as early indicators of genomic instability and increased
cancer risk. The technology includes proprietary mass-tag enhancements designed to improve the sensitivity and specificity of DNA adduct
detection across a full genomic landscape.
Pearsanta intends to
develop this platform to enable a comprehensive, panoramic assessment of DNA adducts using urine, blood, or solid tissue samples. This
approach aims to provide actionable insights into DNA damage before mutations occur, offering the potential to identify environmental
or biological factors that contribute to cancer risk. The development roadmap includes further validation of the technology and the creation
of commercially available diagnostic kits. While still in the early stages, Pearsanta anticipates that additional development over the
next two to three years will advance this platform toward clinical and commercial applications.
ADIVIR ™ ,
INC. Subsidiary
Formed
in April 2023, Adivir™, Inc . (“Adivir”) is a wholly owned subsidiary of Aditxt, Inc., dedicated to advancing
the clinical and commercial development of innovative products intended to address significant unmet needs in infectious disease and population
health.
Adivir
is focused on building a portfolio of antiviral and other antimicrobial solutions designed to target life-threatening viral infections
and emerging pathogens. Its strategic objective is to identify, develop, and commercialize therapeutic candidates that have the potential
to improve treatment access and outcomes in areas where existing options are limited or inadequate.
We
believe the global healthcare landscape underscores the critical importance of strengthening antiviral preparedness and accelerating development
of both novel and repurposed therapeutic solutions. Through Adivir, the Company seeks to contribute to addressing the ongoing and evolving
challenges posed by infectious diseases worldwide.
45
ADIFEM,
INC. Subsidiary
Adifem,
Inc. (“Adifem”), f/k/a Adicure, Inc., was formed in April of 2024 connection with Aditxt’s planned strategic expansion
into women’s health through its proposed acquisition of Evofem Biosciences. Adifem is a wholly owned subsidiary of the Company dedicated
to advancing innovative solutions that address critical unmet needs in women’s health.
Although we are no longer pursuing the acquisition of Evofem Biosciences,
our commitment to women’s health reflects a broader strategic objective to invest in therapeutic areas where there are significant
unmet medical need and opportunity for meaningful patient impact. We believe that empowering women with innovative, science-driven solutions
remains an important and timely priority in global healthcare.
Evofem
Merger Agreement and Termination
On
December 11, 2023 (the “Execution Date”), Aditxt, Inc., a Delaware corporation (the “Company”) entered into an
Agreement and Plan of Merger (the “Merger Agreement”) with Adifem, a Delaware corporation and wholly owned subsidiary of the
Company (“Merger Sub”) and Evofem Biosciences, Inc., a Delaware corporation (“Evofem”), pursuant to which, Merger
Sub will be merged into and with Evofem (the “Merger”), with Evofem surviving the Merger as a wholly owned subsidiary of the
Company.
Subject
to the terms and conditions set forth in the Merger Agreement, at the effective time of the Merger (the “Effective Time”),
(i) all issued and outstanding shares of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”),
other than any shares of Evofem Common Stock held by the Company or Merger Sub immediately prior to the Effective Time, will be converted
into the right to receive an aggregate of 8 shares of the Company’s common stock, par value $0.001 per share; and
(ii) all issued and outstanding shares of Series E-1 Preferred Stock, par value $0.0001 of Evofem (the “Evofem Unconverted
Preferred Stock”), other than any shares of Evofem Unconverted Preferred Stock held by the Company or Merger Sub immediately prior
to the Effective Time, will be converted into the right to receive an aggregate of 2,327 shares of Series A-1 Convertible Preferred
Stock, par value $0.001 of the Company (the “Company Preferred Stock”), having such rights, powers, and preferences set
forth in the form of Certificate of Designation of Series A-1 Convertible Preferred Stock.
On
January 8, 2024, the Company, Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”),
and Evofem Biosciences, Inc., a Delaware corporation (“Evofem”) entered into the First Amendment (the “First Amendment
to Merger Agreement”), to the Agreement and Plan of Merger (the “Merger Agreement”) pursuant to which the parties agreed
to extend the date by which the joint proxy statement would be filed with the SEC until February 14, 2024.
On
January 30, 2024, the Company, Adicure and Evofem entered into the Second Amendment to the Merger Agreement (the “Second Amendment
to Merger Agreement”) to amend (i) the date of the Parent Loan (as defined in the Merger Agreement) to Evofem to be February 29,
2024, (ii) to change the date by which Evofem may terminate the Merger Agreement for failure to receive the Parent Loan to be February
29, 2024, and (iii) to change the filing date for the Joint Proxy Statement (as defined in the Merger Agreement) to April 1, 2024.
46
On
February 29, 2024, the Company, Adicure and Evofem entered into the Third Amendment to the Merger Agreement (the “Third Amendment
to Merger Agreement”) in order to (i) make certain conforming changes to the Merger Agreement regarding the Notes, (ii) extend the
date by which the Company and Evofem will file the joint proxy statement until April 30, 2024, and (iii) remove the requirement that the
Company make the Parent Loan (as defined in the Merger Agreement) by February 29, 2024 and replace it with the requirement that the Company
make an equity investment into Evofem consisting of (a) a purchase of 2,000 shares of Evofem Series F-1 Preferred Stock for
an aggregate purchase price of $2.0 million on or prior to April 1, 2024, and (b) a purchase of 1,500 shares of Evofem
Series F-1 Preferred Stock for an aggregate purchase price of $1.5 million on or prior to April 30, 2024.
On
April 26, 2024, the Company received notice from Evofem (the “Termination Notice”) that Evofem was exercising its right to
terminate the Merger Agreement as a result of the Company’s failure to provide the Initial Parent Equity Investment (as defined
in the Merger Agreement, as amended).
On
May 2, 2024, the Company, Adifem, Inc. f/k/a Adicure, Inc. and Evofem Biosciences, Inc. (“Evofem”) entered into the Reinstatement
and Fourth Amendment to the Merger Agreement (the “Fourth Amendment”) in order to waive and amend, among other things, the
several provisions listed below.
Amendments
to Article VI: Covenants and Agreement
Article
VI of the Merger Agreement is amended to:
●
reinstate the Merger Agreement, as amended by the Fourth Amendment, as if never terminated;
●
reflect the Company’s payment to Evofem, in the amount of $1,000,000 (the “Initial Payment”), via wire initiated by May 2, 2024;
●
delete Section 6.3, which effectively eliminates the “no shop” provision, and the several defined terms used therein;
●
add a new defined term “Company Change of Recommendation;” and
●
revise section 6.10 of the Merger Agreement such that, after the Initial Payment, and upon the closing of each subsequent capital raise by the Company (each a “Parent Subsequent Capital Raise”), the Company shall purchase that number of shares of Evofem’s Series F-1 Preferred Stock, par value $0.0001 per share (the “Series F-1 Preferred Stock”), equal to forty percent (40%) of the gross proceeds of such Parent Subsequent Capital Raise divided by 1,000, up to a maximum aggregate amount of $2,500,000 or 2,500 shares of Series F-1 Preferred Stock. A maximum of $1,500,000 shall be raised prior to September 17, 2024, and $1,000,000 prior to July 1, 2024 (the “Parent Capital Raise”).
47
Amendments
to Article VIII: Termination
Article
VIII of the Merger Agreement is amended to:
●
extend the date after which either party may terminate from May 8, 2024 to July 15, 2024;
●
revise Section 8.1(d) in its entirety to allow Company to terminate at any time after there has been a Company Change of Recommendation, provided that Aditxt must receive ten day written notice and have the opportunity to negotiate a competing offer in good faith; and
●
amend and restate Section 8.1(f) in its entirety, granting the Company the right to terminate the agreement if (a) the full $1,000,000 Initial Payment required by the Fourth Amendment has not been paid in full by May 3, 2024 (b) $1,500,000 of the Parent Capital Raise Amount has not been paid to the Company by June 17, 2024, (c) $1,000,000 of the Parent Capital Raise Amount has not been paid to the Company by July 1, 2024, or (d) Aditxt does not pay any portion of the Parent Equity Investment within five calendar days after each closing of a Parent Subsequent Capital Raise.
Amended and Restated Merger Agreement
On
July 12, 2024 (the “A&R Execution Date”), the Company entered into an Amended and Restated Agreement and Plan of Merger
(the “Merger Agreement”) with Adifem, Inc. f/k/a Adicure, Inc., a Delaware corporation and wholly owned subsidiary of the
Company (“Merger Sub”) and Evofem, pursuant to which, Merger Sub will be merged into and with Evofem (the “Merger”),
with Evofem surviving the Merger as a wholly owned subsidiary of the Company. The Merger Agreement amended and restated that certain Agreement
and Plan of Merger dated as of December 11, 2023, by and among the Company, Merger Sub and Evofem (as amended, the “Original Agreement”).
Effect on Capital Stock
Subject
to the terms and conditions set forth in the Merger Agreement, at the effective time of the Merger (the “Effective Time”),
(i) all issued and outstanding shares of common stock, par value $0.0001 per share of Evofem (“Evofem Common Stock”),
other than any shares of Evofem Common Stock either held by the Company or Merger Sub immediately prior to the Effective Time or which
are Dissenting Shares (as hereinafter defined), will be converted into the right to receive an aggregate of $1,800,000; and (ii) each
issued and outstanding share of Series E-1 Preferred Stock, par value $0.0001 of Evofem (the “Evofem Unconverted Preferred
Stock”), other than any shares of Evofem Unconverted Preferred Stock either held by the Company or Merger Sub immediately prior
to the Effective Time or which are Dissenting Shares, will be converted into the right to receive one (1) share of Series A-2 Preferred
Stock, par value $0.001 of the Company (the “Company Preferred Stock”), having such rights, powers, and preferences set
forth in the form of Certificate of Designation of Series A-2 Preferred Stock, the form of which is attached as Exhibit C to the Merger
Agreement.
Any
Evofem capital stock outstanding immediately prior to the Effective Time and held by an Evofem shareholder who has not voted in favor
of or consented to the adoption of the Merger Agreement and who is entitled to demand and has properly demanded appraisal for such Company
Capital Stock in accordance with the Delaware General Corporation Law (“DGCL”), and who, as of the Effective Time, has not
effectively withdrawn or lost such appraisal rights (such Evofem capital Stock, “Dissenting Shares”) shall not be converted
into or be exchangeable for the right to receive a portion of the Merger Consideration and, instead, shall be entitled to only those rights
as set forth in the DGCL. If, after the Effective Time, any such holder fails to perfect or withdraws or loses his, her or its right to
appraisal under the DGCL, with respect to any Dissenting Shares, upon surrender of the certificate(s) representing such Dissenting Shares,
such Dissenting Shares shall thereupon be treated as if they had been converted as of the Effective Time into the right to receive the
portion of the merger consideration, if any, to which such Evofem capital stock is entitled pursuant to the Merger Agreement, without
interest.
As
a closing condition for the Company, there shall be no more than 4,141,434 Dissenting Shares that are Evofem Common Stock or 98 Dissenting
Shares that are Evofem Preferred Stock.
48
Treatment of Evofem Options and Employee
Stock Purchase Plan
At
the Effective Time, each option outstanding under the Evofem 2014 Equity Incentive Plan, the Evofem 2018 Inducement Equity Incentive Plan
and the Evofem 2019 Employee Stock Purchase Plan (collectively, the “Evofem Option Plans”), whether or not vested, will be
canceled without the right to receive any consideration, and the board of directors of Evofem shall take such action such that the Evofem
Option Plans are cancelled as of the Effective Time.
As
soon as practicable following the A&R Execution Date, Evofem will take all action that may be reasonably necessary to provide that:
(i) no new offering period will commence under the Evofem 2019 Employee Stock Purchase Plan (the “Evofem ESPP”); (ii) participants
in the Evofem ESPP as of the A&R Execution Date shall not be permitted to increase their payroll deductions or make separate non-payroll
contributions to the Evofem ESPP; and (iii) no new participants may commence participation in the Evofem ESPP following the A&R Execution
Date. Prior to the Effective Time, Evofem will take all action that may be reasonably necessary to: (A) cause any offering period or purchase
period that otherwise be in progress at the Effective Time to be the final offering period under the Evofem ESPP and to be terminated
no later than five business days prior to the anticipated closing date (the “Final Exercise Date”); (B) make any pro-rata
adjustments that may be necessary to reflect the shortened offering period or purchase period; (C) cause each participant’s then-outstanding
share purchase right under the Evofem ESPP to be exercised as of the Final Exercise Date; and (D) terminate the Evofem ESPP, as of and
contingent upon, the Effective Time.
Representations and Warranties
The
parties to the Merger Agreement have agreed to customary representations and warranties for transactions of this type.
Covenants
The
Merger Agreement contains various customary covenants, including but not limited to, covenants with respect to the conduct of Evofem’s
business prior to the Effective Time.
Closing Conditions
Mutual
The
respective obligations of each of the Company, Merger Sub and Evofem to consummate the closing of the Merger (the “Closing”)
are subject to the satisfaction or waiver, at or prior to the closing of certain conditions, including but not limited to, the following:
(i)
approval by the Evofem shareholders;
(ii)
the entry into a voting agreement by the Company and certain members of Evofem management;
(iii)
all preferred stock of Evofem other than the Evofem Unconverted Preferred Stock shall have been converted to Evofem Common Stock;
49
(iv)
Evofem shall have received agreements (the “Evofem Warrant Holder Agreements”) from all holders of Evofem warrants which provide:
(a)
waivers with respect to any fundamental transaction, change in control or other similar rights that such warrant holder may have under any such Evofem warrants, and (b) an agreement to such Evofem warrants to exchange such warrants for not more than an aggregate (for all holders of Evofem warrants) of 930,336 shares of Company Preferred Stock;
(v)
Evofem shall have cashed out any other holder of Evofem warrants who has not provided an Evofem Warrant Holder Agreement; and
(vi)
Evofem shall have obtained waivers from the holders of the convertible notes of Evofem (the “Evofem Convertible Notes”) with respect to any fundamental transaction rights that such holder may have under the Evofem Convertible Notes, including any right to vote, consent, or otherwise approve or veto any of the transactions contemplated under the Merger Agreement.
(vii)
The Company shall have received sufficient financing to satisfy its payment obligations under the Merger Agreement.
(viii)
The requisite stockholder approval shall have been obtained by the Company at a Special Meeting of its stockholders to approve the Parent Stock Issuance (as defined in the Merger Agreement) pursuant to the requirements of NASDAQ.
The Company and Merger Sub
The
obligations of the Company and Merger Sub to consummate the Closing are subject to the satisfaction or waiver, at or prior to the Closing
of certain conditions, including but not limited to, the following:
(i)
the Company shall have obtained agreements from the holders of Evofem Convertible Notes and purchase rights they hold to exchange such Convertible Notes and purchase rights for not more than an aggregate (for all holders of Evofem Convertible Notes) of 353 shares of Company Preferred Stock;
(ii)
the Company shall have received waivers from the holders of certain of the Company’s securities which contain prohibitions on variable rate transactions; and
(iii)
the Company, Merger Sub and Evofem shall work together between the A&R Execution Date and the Effective Time to determine the tax treatment of the Merger and the other transactions contemplated by the Merger Agreement.
Evofem
The
obligations of Evofem to consummate the Closing are subject to the satisfaction or waiver, at or prior to the Closing of certain conditions,
including but not limited to, the following:
(i)
The Company shall be in compliance with the stockholders’ equity requirement in Nasdaq Listing Rule 5550(b)(1) and shall meet all other applicable criteria for continued listing.
50
Termination
The
Merger Agreement may be terminated at any time prior to the consummation of the Closing by mutual written consent of the Company and Evofem.
Either the Company or Evofem may also terminate the Merger Agreement if (i) the Merger shall not have been consummated on or before 5:00
p.m. Eastern Time on September 30, 2024; (ii) if any judgment, law or order prohibiting the Merger or the Transactions has become final
and non-appealable; (iii) the required vote of Evofem stockholders was not obtained; or (iv) in the event of any Terminable Breach (as
defined in the Merger Agreement). The Company may terminate the Merger Agreement if (i) prior to approval by the required vote of Evofem’s
shareholders if the Evofem board of directors shall have effected a Company Change in Recommendation (as defined in the Merger Agreement);
or (ii) in the event that the Company determines, in its reasonable discretion, that the acquisition of Evofem could result in a material
adverse amount of cancellation of indebtedness income to the Company. Evofem may terminate the Merger Agreement if (i) at any time after
there has been a Company Change of Recommendation; provided, that Evofem has provided the Company ten (10) calendar days’ prior
written notice thereof and has negotiated in good faith with the Company to provide a competing offer; (ii) the Company’s common
stock is no longer listed for trading on Nasdaq; or (iii) any of: (A) the Initial Parent Equity Investment has not been made by the Initial
Parent Equity Investment Date, (B) the Second Parent Equity Investment has not been made by the Second Parent Equity Investment Date,
(C) the Third Parent Equity Investment has not been made by the Third Parent Equity Investment Date or (D) the Fourth Parent Equity Investment
has not been made by the Fourth Parent Equity Investment Date (as all of such terms are defined in the Merger Agreement).
Effect of Termination
If
the Merger Agreement is terminated, the Merger Agreement will become void, and there will be no liability under the Merger Agreement on
the part of any party thereto.
Amendments to Evofem Amended and Restated
Merger Agreement
On
August 16, 2024, the Company, Merger Sub and Evofem entered into Amendment No. 1 to the Amended and Restated Merger Agreement (“Amendment
No. 1”), pursuant to which the date by which the Company is to make the Third Parent Equity Investment (as defined under the Amended
and Restated Merger Agreement) was amended to the earlier of September 6, 2024 or five (5) business days of the closing of a public offering
by Parent resulting in aggregate net proceeds to Parent of no less than $20,000,000. Except as set forth herein, the terms and conditions
of the Amended and Restated Merger Agreement have not been modified.
On
September 6, 2024, the Company, Merger Sub and Evofem entered into Amendment No. 2 to the Amended and Restated Merger Agreement (“Amendment
No. 2”), pursuant to which the date by which the Company shall make the Third Parent Equity Investment was amended from September
6, 2024 to September 30, 2024 and adjust the amount of such investment from $2 million to $1.5 million, and to extend the date by which
Aditxt shall make the Fourth Parent Equity Investment (as defined under the Amended and Restated Merger Agreement) was amended from September
30, 2024 to October 31, 2024 and adjust the amount of such investment from $1 million to $1.5 million.
Third Evofem Amendment & Parent Equity
Investment
On
October 2, 2024, the Company, Merger Sub and Evofem entered into Amendment No. 3 to the Amended and Restated Merger Agreement in order
to extend the date by which the Company shall make the Third Parent Equity Investment to October 2, 2024, reduce the amount of the Third
Parent Equity Investment from $1.5 million to $720,000, and increase the amount of the Fourth Parent Equity Investment from $1.5 million
to $2.28 million.
On
October 2, 2024, the Company completed the purchase of 460 shares of Evofem F-1 Preferred Stock for an aggregate purchase price of $460,000.
51
Evofem Parent Equity Investment
On
October 28, 2024, the Company entered into a Securities Purchase Agreement (the “Series F-1 Securities Purchase Agreement”)
with Evofem, pursuant to which the Company purchased the Fourth Parent Equity Investment of 2,280 shares of Evofem Series F-1 Convertible
Preferred Stock for an aggregate purchase price of $2,280,000.
Fifth Amendment to Amended
and Restated Merger Agreement
On
March 23, 2025, the Company, Adicure, Inc., and Evofem entered into Amendment No. 5 to the Amended and Restated Merger Agreement (“Amendment
No. 5”), pursuant to which, the parties agreed that (i) Evofem shall use commercially reasonable efforts to hold the Company Shareholders
Meeting (as defined under the A&R Merger Agreement) no later than September 26, 2025, (ii) the Company shall invest an additional
$1,500,000 in Evofem no later than April 7, 2025 in exchange for additional shares of F-1 Preferred Stock and/or, at the Company’s
option, senior subordinated notes of Evofem, and (iii) the End Date shall be extended to September 30, 2025.
Sixth Amendment to Amended
and Restated Merger Agreement
On
August 26, 2025, the Company, Adicure, Inc., and Evofem entered into Amendment No. 6 to the Amended and Restated Merger Agreement(“Amendment
No. 6”), in order to (i) amend Sections 1.5 and 3.1(b)(ii) to update the definition of “Unconverted Company Preferred Stock
“to include Series G-1 Preferred Stock of Evofem; (ii) amend Section 1.6 to update the definition of “Company Shareholder
Approval “to include (a) the outstanding shares of Evofem common stock (including all Evofem preferred stock on the basis and to
the extent it is permitted to so vote) entitled to vote thereon, and (b) each series of the unconverted Evofem preferred stock; (iii)
amend Section 6.23 to clarify that Evofem will assist in obtaining Exchange Agreements (as defined in the Amended and Restated Merger
Agreement) to exchange Evofem convertible notes and purchase rights for an aggregate of not more than 89,021 shares of the Company’s
preferred stock from the applicable Evofem shareholders; (iv) amend Section 7.2(j) to change the number of dissenting shares to no more
than 741,603 shares of common stock or 202 shares of preferred stock; (v) add a new Section 7.2(k) to require waivers from each holder
of Evofem’s Series E-1 Convertible Preferred Stock, with respect to the last sentence of Section 2, the entirety of Section 6, any
price adjustment provisions that may be triggered under Section 8(a)(ii), Section 12(c) and Section 12(d) of the Evofem Series E-1 Certificate
of Designations; and (vi)to replace in its entirety, the Certificate of Designation included as Exhibit C to the Amended and Restated
Merger Agreement.
Evofem Termination
On
October 20, 2025, Aditxt received from Evofem a notice of termination of the parties’ Merger Agreement. In the notice, Evofem cites
Section 8.1(b)(ii) (the end date having passed) and Section 8.1(b)(iv) (failure to obtain shareholder approval at the October 20, 2025
special meeting) as the basis for termination, effective October 20, 2025. No termination fee or other early-termination penalty is payable
by Aditxt in connection with Evofem’s termination pursuant to Sections 8.1(b)(ii) and 8.1(b)(iv). The Company retains its holdings
of Evofem F-1 Preferred Stock, convertible notes, and Evofem Warrants.
52
Our Team
We
have assembled a team of experts from a variety of scientific fields and commercial backgrounds, with many years of collective experience
that ranges from founding startup biotech companies, to developing and marketing biopharmaceutical products, to designing clinical trials,
and to managing private and public companies.
Going Concern
We were incorporated on September
28, 2017 and have not generated significant revenues to date. During the year ended December 31, 2025 we had a net loss of $42,787,043
and cash of $3,198,599 as of December 31, 2025.
We are currently over 90
days past due on a significant number of vendor obligations. The Company will require significant additional capital to operate in the
normal course of business and fund clinical studies in the long-term. We believe our remaining funds on hand will not be sufficient to
fund our operations for the next 12 months and such creates substantial doubt about our ability to continue as a going concern beyond
one year.
Financial Results
We have a limited operating history. Therefore, there is limited historical
financial information upon which to base an evaluation of our performance. Our prospects must be considered in light of the uncertainties,
risks, expenses, and difficulties frequently encountered by companies in their early stages of operations. Our condensed consolidated
financial statements as of December 31, 2025, show a net loss of $42,787,043. We expect to incur additional net expenses over the next
several years as we continue to maintain and expand our existing operations. The amount of future losses and when, if ever, we will achieve
profitability are uncertain.
Results of Operations
Results of operations for the year ended
December 31, 2025 and 2024
We generated revenue of $3,195
and $133,985 for the year ended December 31, 2025 and 2024, respectively. Cost of goods sold for the year ended December 31, 2025 and
2024 was $2,927 and $627,474, respectively. The decrease in revenue and costs of goods sold during the year ended December 31, 2025 compared
to the year ended December 31, 2024 was due to a decrease in AditxtScore TM orders due to decreased COVID testing being
done.
During the year ended December
31, 2025, we incurred a loss from operations of $19,570,724. This is due to general and administrative expenses of $15,974,863, which
includes approximately $4,438,898 in payroll expenses and $5,477,124 in professional fees. Research and development expenses were $3,194,133
which includes $995,473 in consulting expenses. Sales and marketing expenses were $401,996.
During the year ended December
31, 2024, we incurred a loss from operations of $27,863,698. This is due primarily to general and administrative expenses of $16,286,216.
This includes approximately $4,903,086 in payroll expenses, $4,998,772 in professional fees, and $33,071 in stock-based compensation.
Research and development expenses were $10,886,130 which includes $1,772,108 in consulting expenses and $6,712,663 in stock-based compensation.
Sales and marketing expenses were $197,863, which includes $0 in stock-based compensation.
The decrease in expenses
during the year ended December 31, 2025 compared to the year ended December 31, 2024 was due to decreased research and development spend.
During the year ended December 31, 2025, the Company had other expenses of $23,216,319. This was primarily comprised of a loss on the
change in the fair value of the Evofem F-1 preferred stock of $23,766,209, a gain on the change in the fair value of the Evofem warrants
of $2,806,983, and an amortization of debt discount of $1,706,697.
During the year ended December
31, 2024, the Company had other expenses of $7,156,360. This was primarily comprised of an interest expense of $4,188,725 and an amortization
of debt discount of $3,174,920.
53
Liquidity and Capital Resources
We have incurred substantial
operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future and may never
become profitable. As of December 31, 2025, we had an accumulated deficit of $209,808,770. We had working capital of $(8,398,458) as of
December 31, 2025. During the year ended December 31, 2025, we purchased $13,743 in fixed assets.
Our
consolidated financial statements have been prepared assuming that we will continue as a going concern.
We
will need significant additional capital to continue to fund our operations and the clinical trials for our product candidates. We may
seek to sell common stock, preferred stock or convertible debt securities, enter into a credit facility or another form of third-party
funding or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants.
The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have
rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities,
or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party
funding arrangement could require us to relinquish valuable rights.
The
source, timing, and availability of any future financing will depend principally upon market conditions, and, more specifically, on the
progress of our clinical development program. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of
necessary funds may require us to, among other things, delay, scale back or eliminate expenses including some or all our planned development,
including our clinical trials. While we may need to raise funds in the future, we believe the current cash reserves should be sufficient
to fund our operation for the foreseeable future. Because of these factors, we believe that this creates doubt about our ability to continue
as a going concern.
Contractual Obligations
The following table shows
our contractual obligations as of December 31, 2025:
Payment Due by Year
Total
2026
2027
2028
Lease
$
1,288,930
$
801,760
$
389,165
$
98,005
Critical Accounting Policies and Estimates
Our condensed consolidated
financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of
our condensed consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that
affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures. The following involve the most
judgment and complexity:
Fair value of investments in Evofem warrants and convertible
notes receivable
The Company estimates the fair value of its investments in
Evofem warrants and convertible notes receivable using a Monte Carlo simulation model, which incorporates a range of possible future outcomes
and requires significant management judgment. Key assumptions include the expected volatility of Evofem’s equity, early exercise
or conversion behavior, the timing and likelihood of future Evofem financing events that could trigger contractual reset provisions, the
expected term of the instruments, and the applicable risk-free interest rate. Because these inputs are inherently subjective and involve
significant unobservable assumptions, changes in these factors could result in materially different fair value measurements and may have
a material impact on the Company’s financial condition and results of operations.
Investments in Evofem preferred stock
The Company accounts for its investments in Evofem preferred
stock at cost, less impairment, as the securities do not have a readily determinable fair value and the Company has not elected the fair
value option; accordingly, these investments are not remeasured at fair value on a recurring basis. Management evaluates the investment
for impairment each reporting period by considering qualitative and quantitative factors, including Evofem’s financial condition,
operating performance, and prospects, as well as general market conditions and the timing and likelihood of a liquidity event. When events
or changes in circumstances indicate that the carrying amount may not be recoverable, the Company estimates the fair value of the investment
using valuation techniques that incorporate significant unobservable inputs and recognizes an impairment loss in earnings to the extent
the decline in value is determined to be other-than-temporary. Because this assessment requires significant judgment, actual results could
differ materially from these estimates.
Accordingly, we believe the
policies set forth above are critical to fully understanding and evaluating our financial condition and results of operations. If actual
results or events differ materially from the estimates, judgments and assumptions used by us in applying these policies, our reported
financial condition and results of operations could be materially affected.
54
Off-Balance Sheet Arrangements
We did not have during the
periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
JOBS Act
On April 5, 2012, the
JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the
extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards.
In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards
would otherwise apply to private companies.
When favorable, we have chosen
to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying with new
or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.
We are in the process of
evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial
reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted
by the Public Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the
auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion
and analysis. We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year
in which we have total annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth
anniversary of the date of the completion of our IPO (December 31, 2025); (iii) the date on which we have issued more than $1 billion
in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer
under the rules of the SEC.
Nasdaq Equity Compliance
As of the date of filing, on an unaudited basis, the Company has equity of approximately $35.6 million, which exceeds the Nasdaq continued
listing requirement.
Recently Issued and Adopted Accounting Pronouncements
See Note 3 - Summary of Significant
Accounting Policies to the accompanying condensed consolidated financial statements for a description of other accounting policies and
recently issued accounting pronouncements.
Recent Developments
See Note 14 – Subsequent
Event to the accompanying condensed consolidated financial statements for a description of material recent developments.
Item 7A. Quantitative and Qualitative
Disclosures About Market Risk.
We are not required to provide
the information required by this Item as it is a “smaller reporting company,” as defined in Rule 229.10(f)(1).
Item 8. Financial Statements and Supplementary
Data.
See pages F-1 through F-61
following the Exhibit Index of this Annual Report on Form 10-K.
Item 9. Changes in and Disagreements with
Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Assessment of the Effectiveness of Internal
Controls over Financial Reporting
Disclosure Controls and Procedures
In accordance with Rules
13a-15(b) and 15d-15(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we, under the supervision
and with the participation of our Chief Executive Officer and Chief Financial Officer, carried out an evaluation of the effectiveness
of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Exchange
Act) as of the end of the period covered by this Annual Report on Form 10-K. Based on the foregoing, our Chief Executive Officer and
Chief Financial Officer concluded that our disclosure controls and procedures were (a) designed to ensure that the information we are
required to disclose in our reports under the Exchange Act is recorded, processed, and reported in an accurate manner and on a timely
basis and the information that we are required to disclose in our Exchange Act reports is accumulated and communicated to management
to permit timely decisions with respect to required disclosure and (b) operating in a non-effective manner.
55
Change in Internal Control Over Financial
Reporting
No change occurred in our
internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) of the Exchange Act) during the year ended December
31, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Management’s Annual Report on Internal
Control over Financial Reporting
Our management is responsible
for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under
the Exchange Act.
A control system, no matter
how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will
be met. Further, the design of a control system must reflect the fact that there are resource constraints. Because of the inherent limitations
in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any,
within our Company have been detected.
A material weakness is a
deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility
that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely
basis.
Our independent registered
accounting firm determined that we did not maintain effective internal controls over financial reporting and the following material weaknesses
existed as of December 31, 2025:
●
We did not maintain adequate
controls over the documentation of accounting and financial reporting policies and procedures. Specifically, we did not maintain
policies and procedures to ensure account reconciliations were adequately prepared and reviewed by management.
●
We did not have the resources
or retain individuals to adequately draft the consolidated financial statements and notes to ensure them to be in compliance with
accounting principles generally accepted in the US
●
We did not maintain the
sufficient procedures for the identification and cutoff of accounts payable.
●
We did not maintain the
sufficient procedures for the classification and valuation of debt and equity transactions
These material weaknesses
resulted in material misstatements to the financial statements, which were corrected. There were no changes to previously released financial
results. We are in the process of remediating these material weaknesses.
This report does not include
an attestation report of our independent registered public accounting firm regarding our internal control over financial reporting in
accordance with applicable SEC rules that permit us to provide only management´s report in this report.
Item 9B. Other Information.
None .
Item 9C. Disclosure Regarding Foreign Jurisdictions
that Prevent Inspections.
N/A.
56
PART III
Item 10. Directors, Executive Officers
and Corporate Governance
Executive Officers and Directors
Set forth below is certain
information with respect to the individuals who are our directors and executive officers as of December 31, 2025:
Name
Age
Positions
Amro Albanna
56
Chief Executive Officer, Director
Corinne Pankovcin
59
Chief Mergers & Acquisitions Officer
Shahrokh Shabahang, D.D.S., MS, Ph.D.
63
Chief Innovation Officer, Director
Rowena Albanna
60
Chief Operating Officer
Thomas J. Farley
52
Chief Financial Officer
Christopher Porcelli
34
General Counsel & Chief People Officer
Charles Nelson
72
Director
Brian Brady
47
Director
Sylvia Hermina
46
Director
Amro Albanna - Chief Executive Officer
Mr. Albanna has been our
Chief Executive Officer and a Director since we were formed in 2017. He also served as our President from our inception through September
2021. In 2010, Mr. Albanna co-founded Innovation Economy Corporation (“IEC”), formed to license and commercialize innovations
and create a group of life and health subsidiaries. From 2010 until 2017, Mr. Albanna was Chief Executive Officer and a Director of IEC
and Olfactor Laboratories, Inc., a majority-owned subsidiary of IEC. From 2010 to August 2016, he was the Chief Executive Officer and
a Director of Nano Engineered Applications, Inc., another majority-owned subsidiary of IEC. In 2003, Mr. Albanna founded Qmotions, Inc.
(subsequently renamed Deal A Day Group Corp.). He served as its Chief Executive Officer and a Director until 2011. Qmotions used 3-D
spatial tracking and pattern recognition technologies to develop motion-capturing video game controllers. In 2002, Mr. Albanna was a
co-founder of Digital Angel Corporation - a company formed via the merger of three private companies (one being TTC below) into a fourth
publicly traded company (American Stock Exchange) and was placed in charge of commercializing its GPS/wireless technologies. Around that
time, Mr. Albanna co-founded an incubator for startups at the University of California, Riverside Research Park which was acquired in
2007. In 1997, he founded Timely Technology Corporation (“TTC”), which designed and developed e-commerce software for education,
retail and finance. TTC was acquired in 2000 by a Nasdaq-listed company. Mr. Albanna graduated from California State University San Bernardino
in 1991 with a B.S. in Business Administration with concentration in Computer Information Systems. He completed graduate coursework in
Computer Science and Engineering at California State University, Long Beach from 1992 to 1993. In 2019, Mr. Albanna completed coursework
in Immunology and Genetics at Harvard Medical School HMX online learning platform.
Corinne Pankovcin - Chief Mergers
and Acquisitions Officer
Ms. Pankovcin has been our
Chief Mergers and Acquisitions Officer since January 2024. Ms. Pankovcin served as the Chief Commercialization Officer from April 2023
through January 2024. Ms. Pankovcin served as our President from September 2021 through April 2023. Ms. Pankovcin served as our Chief
Financial Officer from July 2020 through August 2021. From December 2015 to July 2019, Ms. Pankovcin was the Chief Financial Officer
and Managing Director and Treasurer of Business Development Corporation of America (“BDCA”), a business development company.
Prior thereto, from January 2011 to August 2015, Ms. Pankovcin was the Chief Financial Officer and Treasurer of Blackrock Capital Investment
Corporation (NASDAQ: BKCC), and a Managing Director of Finance at BlackRock Investment Management LLC. Prior to joining BlackRock, Ms.
Pankovcin was a senior member of Finance & Accounting of Alternative Investments and served as Chief Financial Officer for the Global
Emerging Markets products group at AIG Capital Partners. Ms. Pankovcin began her career with PricewaterhouseCoopers LLP, where she ultimately
held the role of Senior Manager of Business Assurance for Consumer Products, Manufacturing, and Middle Market industries from 1991 to
2001. Ms. Pankovcin earned her B.S. in Accounting from Dowling College and her Master’s Degree in Business Administration from
Hofstra University. She is a Certified Public Accountant.
57
Shahrokh Shabahang, D.D.S., MS, Ph.D. - Chief Innovation
Officer
Dr. Shabahang has been our
Chief Innovation Officer and Director since our inception. In 2009, Dr. Shabahang co-founded Sekris Biomedical Inc. to incubate immunotherapy
technologies. He served as its Chairman of the board and Chief Executive Officer since its inception. In 2004, Dr. Shabahang joined Genelux
Corporation to lead its clinical development program and to serve as board secretary. Genelux developed an oncolytic virus technology
for treatment of cancer, co-invented by Dr. Shabahang. During his tenure from 2004-2007, Genelux raised $20M+ and obtained regulatory
approval to initiate First-In-Human clinical studies in Europe with patients who had not responded to chemotherapy. In 2001, Dr. Shabahang
became the Director of the Microbiology and Molecular Biology Lab at Loma Linda University (“LLU”). He led the research and
development of an antimicrobial therapeutic agent for treatment of dental infections, which was licensed and marketed by one of the largest
dental distribution companies. Dr. Shabahang attended the University of California, Santa Barbara from 1982 to 1984 and later received
his DDS from the University of Pacific in 1987. He earned his PhD in Microbiology and Molecular Genetics at LLU in 2001. During the same
year, he established his laboratory at LLU to study infectious diseases and host immune responses.
Rowena Albanna - Chief Operating Officer
Ms. Albanna has been our
Chief Operating Officer since July 2020. From 2017 to immediately prior to her appointment as Chief Operating Officer, Ms. Albanna was
an independent operations consultant for the Company. Prior thereto, from 2013 to 2017, Ms. Albanna was the Chief Operating Officer of
Innovation Economy Corporation (“IEC”), formed to license and commercialize innovations and create a group of life and health
subsidiaries. From 2010 to 2013, Ms. Albanna was Senior Vice President of IEC. From 2004 to 2009, Ms. Albanna was the founder and principal
of Weezies, an online-based business focused on building and operating e-commerce stores and affiliate marketing sites. From 2003 to
2004, Ms. Albanna was the head of Product Development and Engineering of Qmotions Inc. Qmotions used 3-D spatial tracking and pattern
recognition technologies to develop motion-capturing video game controllers. In 2002, Ms. Albanna was VP of Product Development at Digital
Angel Systems where she led the development of devices which combined GPS, wireless, and biosensing. Prior to that, Ms. Albanna held
multiple product development roles with increasing responsibilities for various technology companies in the areas of financial, medical,
telecommunications, integrated circuit layout design, and defense. Ms. Albanna is a co-inventor of two patents related to systems for
localizing, monitoring, and sensing objects. Ms. Albanna received a Bachelor of Science degree in Computer Science with a minor in Mathematics
from California State University, San Bernardino in 1988. Ms. Albanna is the wife of Amro Albanna, our Chief Executive Officer.
Thomas J. Farley, CPA - Chief Financial
Officer
Mr. Farley has been the Chief
Financial Officer since September 2021. Prior to this, Mr. Farley was the Principal Accounting Officer and Controller from October of
2020 to September 2021. From December 2015 to June 2020, Mr. Farley was the Controller of Business Development Corporation of America
(“BDCA”), a publicly listed business development company. Prior thereto, from January 2011 to August 2015, Mr. Farley was
the Senior Controller of Blackrock Capital Investment Corporation (NASDAQ: BKCC). Prior to joining BlackRock Capital Investment Corporation,
Mr. Farley was a Senior Controller for PineBridge Investments Emerging Markets practice. Mr. Farley was also an Accounting Manager for
Bessemer Venture Partners prior to his tenure at PineBridge. Mr. Farley began his career with PricewaterhouseCoopers LLP, from 1996 to
2001. Mr. Farley earned his B.S. in Accounting from Long Island University and is a Certified Public Accountant.
Christopher Porcelli – General
Counsel & Chief People Officer
Mr. Porcelli has served as
our General Counsel and Chief People Officer since September 2025. Prior to this, from October 2020 to June 2025, he served in senior
legal and HR roles at Aterian, Inc. (Nasdaq: ATER), including General Counsel, Head of People & Corporate Secretary (2023–2025).
Previously, he was an associate in the M&A group at Sidley Austin LLP in New York and a corporate associate at Cadwalader, Wickersham
& Taft LLP in New York. He received his J.D. from New York University School of Law and his B.A. from St. John’s University
and is admitted to practice in New York.
Brian Brady - Director
Mr. Brady has served as a Director since December
1, 2018. Mr. Brady was Director of Investments at a large hospital system from March 2016 to December 2022 and returned to this role in
2026 after serving as President of a family office. In his current role, he is responsible for the management of investment activity related
to the organization and personal investments of the family that owns that company. From December 2011 to March 2016, Mr. Brady was the
Vice President/Portfolio Manager at a wealth advisory firm, where he served in an investment advisory role, including asset and portfolio
management. Mr. Brady graduated in 2001 with a bachelor’s degree in finance from the University of Illinois at Chicago and in 2014
with a Master of Business Administration degree from the University of Chicago. We believe that Mr. Brady’s extensive experience
with financial markets and management of investment activities qualifies him to serve as a director of our Company.
58
Charles Nelson - Director
Mr. Nelson has served as
a director since November 2023. Prior to his appointment as a member of the Board, Mr. Nelson was a consultant to the Company from September
2020 through September 2023. He began his financial career as a market representative with American International Group and in 1979 joined
Dean Witter Reynolds as a Financial Advisor, working with high net worth and institutional clients. In 1980, he joined Drexel Burnham
and Lambert, and subsequently, at Ladenberg Thalmann and then at Auerbach Pollack and Richardson originating equity and investment banking
transactions. Over the last 20 years, Mr. Nelson has been involved with financing companies in the fintech, healthcare and bio-pharma
spaces through private equity and public financing including listings on the Nasdaq and the NYSE. We believe that Mr. Nelson’s
extensive experience in capital markets qualifies him to serve as a director of our Company.
Sylvia Hermina - Director
Sylvia Hermina has over 20
years of experience advising public companies on corporate governance, mergers and acquisitions, and shareholder relations. Ms. Hermina currently
serves as Senior Vice President of Kingsdale Advisors, a governance and proxy solicitation firm. Prior to joining Kingsdale
Advisors, Ms. Hermina served as Senior Vice President of Laurel Hill Advisory Group, LLC - a shareholder communications and advisory
firm; Managing Director of The Altman Group, Inc. - a proxy advisory firm. She also held senior positions Georgeson Shareholder Communications
and Corporate Investor Communications, Inc. Ms. Hermina holds a Bachelor of Science degree in Business Administration,
Management and Marketing from Montclair State University. Sylvia is a member of the Society of Corporate Governance (Society),
the National Investor Relations Institute (NIRI) and Chief.
Board Leadership Structure and Risk Oversight
The Board oversees our business
and considers the risks associated with our business strategy and decisions. The Board currently implements its risk oversight function
as a whole. Each of the Board committees, when established, will also provide risk oversight in respect of its areas of concentration
and reports material risks to the Board for further consideration.
Term of Office
Officers hold office until
his or her successor is elected and qualified. Directors are appointed to serve for one year until the meeting of the Board following
the annual meeting of stockholders and until their successors have been elected and qualified.
Director Independence
We use the definition of
“independence” of The Nasdaq Stock Exchange LLC (“Nasdaq”) listing rules to make this determination. Nasdaq listing
rules provide that an “independent director” is one who the board “affirmatively determines” has no “material
relationship” with the company “either directly or as a partner, shareholder or officer of an organization that has a relationship
with the Company. Nasdaq listing rules provide that a director cannot be considered independent if:
●
the director is, or has
been within the last three (3) years, an employee of the Company or an immediate family member of director is, or has been within
the last three (3) years, an executive officer of the Company;
●
the director has received,
or has an immediate family member who is an executive officer of the Company and has received, during any twelve-month period within
the last three (3) years, more than $120,000 compensation directly from the Company (not including compensation received for director
service, pension plan payments or deferred compensation for prior service not contingent on continued service);
●
the director or an immediate
family member is a current partner of the Company’s internal or external auditor; the director is a current employee of the
auditor; an immediate family member is a current employee of the auditor and personally works on the Company’s audit; or the
director or an immediate family member was within the last three (3) years a partner or employee of the auditor and personally worked
on the Company’s audit within that time;
●
the director or an immediate
family member is, or has been within the last three (3) years, employed as an executive officer of another company where any of the
Company’s present executive officers at the same time serves or served on that company’s compensation committee; or
59
●
the director is a current
employee, or an immediate family member is a current executive officer, of an organization that has made to or received from the
Company payments for property or services in an amount which, in any of the last three fiscal (3) years, exceeds greater of 2% of
such other company’s consolidated gross revenues or $1 million. Charitable contributions not considered “payments”
for purposes of this prohibition but contributions meeting these thresholds must be disclosed on the Company’s website or in
its annual proxy statement or its Annual Report on Form 10-K.
Under such definitions, we
consider Mr. Nelson, Mr. Brady, and Ms. Hermina to be “independent.” Nasdaq listing rules permits a phase-in period of up
to one year for an issuer registering securities in an initial public offering to comply with its requirement that a majority of the
board of directors be made up of independent directors. However, our common stock is not currently quoted or listed on any national exchange
or interdealer quotation system with a requirement that a majority of our Board be independent and, therefore, the Company is not subject
to any director independence requirements. We are subject to Nasdaq’s director independence requirements and are required to structure
our board of directors accordingly.
Committees of the Board
Our board of directors has
established three standing committees: Audit, Compensation, and Nominating and Corporate Governance. Each of these standing committees
operate pursuant to its respective charter. The committee charters are reviewed annually by the Nominating and Corporate Governance Committee.
If appropriate, and in consultation with the chairs of the other committees, the Nominating and Corporate Governance Committee may propose
revisions to the charters. The responsibilities of each committee are described in more detail below.
Nasdaq listing rules permits
a phase-in period for an issuer registering securities in an initial public offering to meet the Audit Committee, Compensation Committee
and Nominating and Corporate Governance Committee independence requirements. Under the initial public offering phase-in period, only
one member of each committee is required to satisfy the heightened independence requirements at the time our registration statement becomes
effective, a majority of the members of each committee must satisfy the heightened independence requirements within 90 days following
the effectiveness of our registration statement, and all members of each committee must satisfy the heightened independence requirements
within one year from the effectiveness of our registration statement.
The composition
and functions of each committee are described below.
Name
Independent
Audit
Nominating and
Corporate
Governance
Compensation
Amro Albanna
Shahrokh Shabahang, D.D.S., MS, Ph.D.
Brian Brady
X
X *
X
X
Charles Nelson
X
X
X
X *
Sylvia Hermina
X
X
X
*
X
*
Chairman of the committee
Audit Committee
The Audit Committee,
among other things, is responsible for:
●
appointing; approving the
compensation of; overseeing the work of; and assessing the independence, qualifications, and performance of the independent auditor;
●
reviewing the internal
audit function, including its independence, plans, and budget;
●
approving, in advance,
audit and any permissible non-audit services performed by our independent auditor;
●
reviewing our internal
controls with the independent auditor, the internal auditor, and management;
60
●
reviewing the adequacy
of our accounting and financial controls as reported by the independent auditor, the internal auditor, and management;
●
overseeing our financial
compliance system; and
●
overseeing our major risk
exposures regarding the Company’s accounting and financial reporting policies, the activities of our internal audit function,
and information technology.
The Board has affirmatively
determined that each member of the Audit Committee meets the additional independence criteria applicable to audit committee members under
SEC rules and Nasdaq listing rules. The Board has adopted a written charter setting forth the authority and responsibilities of the Audit
Committee. The Board has affirmatively determined that each member of the Audit Committee is financially literate, and that Mr. Brady
meets the qualifications of an Audit Committee financial expert.
The Audit Committee consists
of Mr. Brady, Mr. Nelson, and Ms. Hermina. Mr. Brady chairs the Audit Committee.
Compensation Committee
The Compensation
Committee is responsible for:
●
reviewing and making recommendations
to the Board with respect to the compensation of our officers and directors, including the CEO;
●
overseeing and administering
the Company’s executive compensation plans, including equity-based awards;
●
negotiating and overseeing
employment agreements with officers and directors; and
●
overseeing how the Company’s
compensation policies and practices may affect the Company’s risk management practices and/or risk-taking incentives.
The Board has
adopted a written charter setting forth the authority and responsibilities of the Compensation Committee.
The Compensation Committee
consists of Mr. Brady, Mr. Nelson, and Ms. Hermina. Mr. Nelson serves as chairman of the Compensation Committee. The Board has affirmatively
determined that each member of the Compensation Committee meets the independence criteria applicable to compensation committee members
under SEC rules and Nasdaq listing rules.
Nominating and Corporate Governance Committee
The Nominating
and Corporate Governance Committee, among other things, is responsible for:
●
reviewing and assessing
the development of the executive officers and considering and making recommendations to the Board regarding promotion and succession
issues;
●
evaluating and reporting
to the Board on the performance and effectiveness of the directors, committees and the Board as a whole;
●
working with the Board
to determine the appropriate and desirable mix of characteristics, skills, expertise and experience, including diversity considerations,
for the full Board and each committee;
61
●
annually presenting to
the Board a list of individuals recommended to be nominated for election to the Board;
●
reviewing, evaluating,
and recommending changes to the Company’s Corporate Governance Principles and Committee Charters;
●
recommending to the Board
individuals to be elected to fill vacancies and newly created directorships;
●
overseeing the Company’s
compliance program, including the Code of Conduct; and
●
overseeing and evaluating
how the Company’s corporate governance and legal and regulatory compliance policies and practices, including leadership, structure,
and succession planning, may affect the Company’s major risk exposures.
The Board of Directors has
adopted a written charter setting forth the authority and responsibilities of the Nominating and Corporate Governance Committee.
The Nominating and Corporate
Governance Committee consists of Ms. Hermina, Mr. Brady, and Mr. Nelson. Ms. Hermina serves as chairman of the Nominating and Corporate
Governance Committee. The Company’s Board of Directors has determined that each member of the Nominating and Corporate Governance
Committee is independent within the meaning of the independent director guidelines of Nasdaq listing rules.
Compensation Committee Interlocks and Insider
Participation
None of the Company’s
executive officers serves, or in the past has served, as a member of the board of directors or compensation committee, or other committee
serving an equivalent function, of any entity that has one or more executive officers who serve as members of the Company’s board
of directors or its compensation committee. None of the members of the Company’s compensation committee is, or has ever been, an
officer or employee of the Company. There are no interlocking relationships as defined in the applicable SEC rules.
Code of Business Conduct and Ethics
The Company’s board
of directors adopted a code of business conduct and ethics applicable to its employees, directors and officers, in accordance with applicable
U.S. federal securities laws and the corporate governance rules of the Nasdaq Capital Market. The code of business conduct and ethics
is publicly available on the Company’s website. Any substantive amendments or waivers of the code of business conduct and ethics
or code of ethics for senior financial officers may be made only by the Company’s board of directors and will be promptly disclosed
as required by applicable U.S. federal securities laws and the corporate governance rules of the Nasdaq Capital Market.
Corporate Governance Guidelines
The Company’s board
of directors has adopted corporate governance guidelines in accordance with the corporate governance rules of the Nasdaq Capital Market.
Involvement in Certain Legal Proceedings
To our knowledge,
none of our current directors or executive officers has, during the past ten years:
●
been convicted in a criminal
proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);
●
had any bankruptcy petition
filed by or against the business or property of the person, or of any partnership, corporation or business association of which he
or she was a general partner or executive officer, either at the time of the bankruptcy filing or within two years prior to that
time;
●
been subject to any order,
judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or federal or state
authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his involvement in any type of business,
securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons
engaged in any such activity;
62
●
been found by a court of
competent jurisdiction in a civil action or by the SEC or the Commodity Futures Trading Commission to have violated a federal or
state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;
●
been the subject of, or
a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended
or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any
federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance
companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty
or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire
fraud or fraud in connection with any business entity; or
●
been the subject of, or
a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined
in Section 3(a)(26) of the Securities Exchange Act of 1934, as amended (the Exchange Act)), any registered entity (as defined in
Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association, entity or organization that has disciplinary
authority over its members or persons associated with a member.
Except as set forth above
and in our discussion below in “ Certain Relationships and Related Transactions ,” none of our directors or executive
officers has been involved in any transactions with us or any of our directors, executive officers, affiliates or associates which are
required to be disclosed pursuant to the rules and regulations of the SEC.
Other than as set forth below,
we are not currently a party to any legal proceedings, the adverse outcome of which, individually or in the aggregate, we believe will
have a material adverse effect on our business, financial condition or operating results.
Item 11. Executive Compensation
The following table represents
information regarding the total compensation for the named executive officers of the Company as of 2025 and 2024:
Name and
Principal Position
Year
Salary (1)
($)
Bonus
($)
Stock
Awards
($)
Option
Awards
($)
Restricted
Stock
Units
($)
All
Other
Compensation
($)
Total
($)
Amro
Albanna
2025
500,000
-
-
-
-
-
500,000
Chief
Executive Officer and Director
2024
500,000
-
-
-
-
-
500,000
Shahrokh
Shabahang, D.D.S., MS, Ph.D.
2025
325,000
-
-
-
-
-
325,000
Chief
Innovation Officer
2024
325,000
-
-
-
-
-
325,000
Corinne
Pankovcin
2025
385,008
-
-
-
-
-
385,008
Chief
Mergers & Acquisitions Officer
2024
385,008
-
-
-
-
-
385,008
Thomas
J. Farley
2025
395,000
-
-
-
-
-
395,000
Chief
Financial Officer
2024
464,616
-
-
-
-
-
464,616
Option awards represent granted
options at the fair market value as of the date of grant. Restricted stock units represent granted restricted stock units at the fair
market value as of the date of grant.
(1)
Salary is reflected on
an accrued basis. From time to time in 2025 and 2024 management has voluntarily forgone their salaried payroll.
63
Employment Agreements
Amro Albanna, Chief Executive Officer
On November 14, 2021, the
Company entered into an Amended and Restated Employment Agreement with Mr. Amro Albanna, the Chief Executive Officer of the Company (the
“Amro Employment Agreement”). Pursuant to the Amro Employment Agreement, Mr. Albanna will receive (i) a base salary at the
annual rate of $280,000 for the remainder of calendar year 2021, and effective January 1, 2022, $500,000 (prorated for any partial year)
payable in bimonthly installments (ii) the opportunity to earn an annual bonus of 2% of the Company’s earnings before interest,
taxes, depreciation, and amortization (EBITDA) with respect to an applicable year for which the bonus is payable, provided that such
bonus will not exceed two (2) times Mr. Albanna’s base salary, and (iii) eligible to earn an annual discretionary bonus as determined
by the Board or its Compensation Committee in their sole discretion. In addition, for calendar year 2021, Mr. Albanna will be eligible
to earn an additional discretionary bonus as determined by the Company.
The term of Mr.
Albanna’s engagement under the Amro Employment Agreement commences as of the Effective Date (as defined in the Amro Employment
Agreement) and continues until November 14, 2023, unless earlier terminated in accordance with the terms of the Amro Employment Agreement.
The term of Mr. Albanna’s Employment Agreement is automatically renewed for successive one (1) year periods until terminated by
Mr. Albanna or the Company.
Under the Amro Employment
Agreement, termination of Mr. Albanna by the Company for “Cause,” “Death,” or “Disability,” (as such
terms are defined in the Amro Employment Agreement), or resignation by Mr. Albanna without “Good Reason” (as defined in the
Amro Employment Agreement), will not require the Company to pay severance to Mr. Albanna. Upon any such termination, Mr. Albanna will
be entitled to receive any Accrued Compensation (as defined in the Amro Employment Agreement), which in the case of termination by the
Company for Cause or resignation by Mr. Albanna for Good Reason will not include payment of pro rata bonus; provided , however ,
if termination of Mr. Albanna by the Company without “Cause” or resignation by Mr. Albanna for “Good Reason,”
then under the Amro Employment Agreement will require the Company to pay severance to Mr. Albanna. Upon any such termination, Mr. Albanna
will be entitled to receive any Accrued Compensation and, subject to Mr. Albanna’s execution of an irrevocable release, receive
(i) on the sixtieth day (60th) day following termination, a lump sum amount equal to twelve (12) months base salary then in effect as
of the date of termination, less applicable taxes and withholdings; (ii) provide reimbursement to Mr. Albanna’s medical insurance
premiums for a period of twelve (12) months following the date of termination; and (iii) cause any equity awards granted prior to the
Effective Date (as defined in the Amro Employment Agreement), that are then outstanding and unvested to immediately vest and, with respect
to all options and stock appreciation rights, to become fully exercisable.
Notwithstanding the foregoing,
under the Amro Employment Agreement, termination of Mr. Albanna by the Company without Cause or resignation by Mr. Albanna for Good Reason
and a Change of Control (as defined in the Amro Employment Agreement) of the Company occurs within six (6) months after such termination,
or within twenty-four (24) months prior to such termination, the Company will pay severance to Mr. Albanna in connection to such termination.
Upon such termination, Mr. Albanna will be entitled to receive any Accrued Compensation, and subject to Mr. Albanna’s execution
of an irrevocable release, receive (i) on the sixtieth (60th) day of termination, a lump sum cash-payment equal to the product of three
times Mr. Albanna’s salary then in effect as of the date of termination, less applicable taxes and withholdings; (ii) provide reimbursement
to Mr. Albanna’s medical insurance premiums for a period of twenty-four (24) months following the date of termination; and (iii)
notwithstanding any provision of any stock incentive plan, stock option agreement, realization bonus, restricted stock agreement or other
agreement relating to capital stock of the Company, cause any equity awards granted prior to that are then outstanding and unvested to
immediately vest and, with respect to all options and stock appreciation rights, to become fully exercisable for twenty-four (24) months
(but not later than when the award would otherwise expire).
The Amro Employment
Agreement also contains customary non-solicitation and non-competition covenants, which covenants remain in effect for twelve (12) months
following any cessation of employment with respect to Mr. Albanna. To the extent any of the payments or benefits provided for under the
Amro Employment Agreement or any other agreement or arrangement between Mr. Albanna and the Company (collectively, the “Payments”),
(a) constitute an “excess parachute payment” within the meaning of Section 280G (“Section 280G”) of the Internal
Revenue Code of 1986, as amended and restated (the “Code”), and (b) would otherwise be subject to the excise tax imposed
by Section 4999 of the Code (“Section 4999”), then the Company will pay or provide the greater (whichever gives Mr. Albanna
the highest net after-tax amount) of (i) all of the Payments or (ii) the portion of Payments not in excess of the greatest amount of
Payments that can be paid that would not result in the imposition of the excise tax under Section 4999.
64
Corinne Pankovcin, Chief Mergers and Acquisitions
Officer
On November 14, 2021, the
Company entered into a new employment agreement (the “Pankovcin Employment Agreement”) with the Company’s President,
Corinne Pankovcin, pursuant to which Ms. Pankovcin will continue to serve as the Company’s President and Secretary until the date
upon which Ms. Pankovcin’s employment may be terminated in accordance with the terms of the Pankovcin Employment Agreement.
The term of Ms. Pankovcin’s
engagement under the Pankovcin Employment Agreement commences as of the Effective Date (as defined in the Pankovcin Employment Agreement)
and continues until November 14, 2023, unless earlier terminated in accordance with the terms of the Pankovcin Employment Agreement.
The term of Ms. Pankovcin’s Employment Agreement is automatically renewed for successive one (1) year periods until terminated
by Ms. Pankovcin or the Company.
Pursuant to the Pankovcin
Employment Agreement, Ms. Pankovcin will receive: (i) a base salary at the annual rate of $250,000 for the remainder of calendar year
2021, and effective January 1, 2022, $385,000 (prorated for any partial year) payable in bimonthly installments and (ii) eligible to
earn an annual discretionary bonus with a target amount of 45% of Base Compensation, which is based on the achievement of performance
objectives, which will be determined by the Board and Compensation Committee. In addition, for calendar year 2021, Ms. Pankovcin shall
be eligible to earn an additional discretionary bonus as determined by the Company.
Under the Pankovcin Employment
Agreement, termination of Ms. Pankovcin by the Company for “Cause,” “Death,” or “Disability,” (as
such terms are defined in the Pankovcin Employment Agreement), or resignation by Ms. Pankovcin for “Good Reason” (as defined
in the Pankovcin Employment Agreement), will not require the Company to pay severance to Ms. Pankovcin. Upon any such termination, Ms.
Pankovcin will be entitled to receive any Accrued Compensation (as defined in the Pankovcin Employment Agreement), which in the case
of termination by the Company for Cause or resignation by Ms. Pankovcin for Good Reason will not include payment of pro rata bonus; provided , however ,
if termination of Ms. Pankovcin by the Company without “Cause” or resignation by Ms. Pankovcin for “Good Reason,”
then under the Pankovcin Employment Agreement will require the Company to pay severance to Ms. Pankovcin. Upon any such termination,
Ms. Pankovcin will be entitled to receive any Accrued Compensation and, subject to Ms. Pankovcin’s execution of an irrevocable
release, receive: (i) on the sixtieth day (60th) day following termination, a lump sum amount equal to twelve (12) months base salary
then in effect as of the date of termination, less applicable taxes and withholdings; (ii) provide reimbursement to Ms. Pankovcin’s
medical insurance premiums for a period of twelve (12) months following the date of termination; and (iii) cause any equity awards granted
prior to the Effective Date (as defined in the Pankovcin Employment Agreement), that are then outstanding and unvested to immediately
vest and, with respect to all options and stock appreciation rights, to become fully exercisable.
Notwithstanding the foregoing,
under the Pankovcin Employment Agreement, termination of Ms. Pankovcin by the Company without Cause or resignation by Ms. Pankovcin for
Good Reason and a Change of Control (as defined in the Pankovcin Employment Agreement) of the Company occurs within six (6) months after
such termination, or within twenty-four (24) months prior to such termination, the Company will pay severance to Ms. Pankovcin in connection
to such termination. Upon such termination, Ms. Pankovcin will be entitled to receive any Accrued Compensation, and subject to Ms. Pankovcin’s
execution of an irrevocable release, receive (i) on the sixtieth (60th) day of termination, a lump sum cash-payment equal to the sum
of (A) the product of two times Ms. Pankovcin’s salary then in effect as of the date of termination, less applicable taxes and
withholdings, and (B) the product of two times Ms. Pankovcin’s Target Bonus; (ii) provide reimbursement to Ms. Pankovcin’s
medical insurance premiums for a period of twenty-four (24) months following the date of termination; and (iii) notwithstanding any provision
of any stock incentive plan, stock option agreement, realization bonus, restricted stock agreement or other agreement relating to capital
stock of the Company, cause any equity awards granted prior to that are then outstanding and unvested to immediately vest and, with respect
to all options and stock appreciation rights, to become fully exercisable for twenty-four (24) months (but not later than when the award
would otherwise expire).
The Pankovcin
Employment Agreement also contains customary non-solicitation and non-competition covenants, which covenants remain in effect for twelve
(12) months following any cessation of employment with respect to Ms. Pankovcin. To the extent any of the payments or benefits provided
for under the Pankovcin Employment Agreement or any other agreement or arrangement between Ms. Pankovcin and the Company (collectively,
the “Payments”), (a) constitute an “excess parachute payment” within the meaning of Section 280G (“Section
280G”) of the Internal Revenue Code of 1986, as amended and restated (the “Code”), and (b) would otherwise be subject
to the excise tax imposed by Section 4999 of the Code (“Section 4999”), then the Company will pay or provide the greater
(whichever gives Ms. Pankovcin the highest net after-tax amount) of (i) all of the Payments or (ii) the portion of Payments not in excess
of the greatest amount of Payments that can be paid that would not result in the imposition of the excise tax under Section 4999.
65
Thomas J. Farley, Chief Financial Officer
On November 14, 2021, the
Company entered into a new employment agreement (the “Farley Employment Agreement”) with the Company’s Chief Financial
Officer, Thomas Farley, pursuant to which Mr. Farley will continue to serve as the Company’s Chief Financial Officer until the
date upon which Mr. Farley’s employment may be terminated in accordance with the terms of the Farley Employment Agreement.
The term of Mr. Farley’s
engagement under the Farley Employment Agreement commences as of the Effective Date (as defined in the Farley Employment Agreement) and
continues until November 14, 2023, unless earlier terminated in accordance with the terms of the Farley Employment Agreement. The term
of Mr. Farley’s Employment Agreement is automatically renewed for successive one (1) year periods until terminated by Mr. Farley
or the Company.
Pursuant to the Farley Employment
Agreement, Mr. Farley will receive: (i) a base salary at the annual rate of $225,000 for the remainder of calendar year 2021, and effective
January 1, 2022, $355,000 (prorated for any partial year) payable in bimonthly installments and, (ii) eligible to earn an annual discretionary
bonus with a target amount of 40% of Base Compensation, which is based on the achievement of performance objectives, which will be determined
by the Board and Compensation Committee. In addition, for calendar year 2021, Mr. Farley will be eligible to earn an additional discretionary
bonus as determined by the Company.
Under the Farley Employment
Agreement, termination of Mr. Farley by the Company for “Cause,” “Death,” or “Disability,” (as such
terms are defined in the Farley Employment Agreement), or resignation by Mr. Farley without “Good Reason” (as defined in
the Farley Employment Agreement), will not require the Company to pay severance to Mr. Farley. Upon any such termination, Mr. Farley
will be entitled to receive any Accrued Compensation (as defined in the Farley Employment Agreement which in the case of termination
by the Company for Cause or resignation by Mr. Farley for Good Reason will not include payment of pro rata bonus; provided , however ,
if termination of Mr. Farley by the Company without “Cause” or resignation by Mr. Farley for “Good Reason,” then
under the Farley Employment Agreement will require the Company to pay severance to Mr. Farley. Upon any such termination, Mr. Farley
will be entitled to receive any Accrued Compensation and, subject to Mr. Farley’s execution of an irrevocable release, receive
(i) on the sixtieth day (60th) day following termination, a lump sum cash-payment equal to the sum of (A) the product of two times Mr.
Farley’s salary then in effect as of the date of termination, less applicable taxes and withholdings, and (B) the product of two
times Mr. Farley’s Target Bonus (as defined in the Farley Employment Agreement); (ii) provide reimbursement to Mr. Farley’s
medical insurance premiums for a period of twelve (12) months following the date of termination; and (iii) cause any equity awards granted
prior to the Effective Date (as defined in the Farley Employment Agreement), that are then outstanding and unvested to immediately vest
and, with respect to all options and stock appreciation rights, to become fully exercisable.
Notwithstanding the foregoing,
under the Farley Employment Agreement, termination of Mr. Farley by the Company without Cause or resignation by Mr. Farley for Good Reason
and a Change of Control (as defined in the Farley Employment Agreement) of the Company occurs within six (6) months after such termination,
or within twenty-four (24) months prior to such termination, the Company will pay severance to Mr. Farley in connection to such termination.
Upon such termination, Mr. Farley will be entitled to receive any Accrued Compensation, and subject to Mr. Farley’s execution of
an irrevocable release, receive (i) on the sixtieth (60th) day of termination, a lump sum cash-payment equal to the product of two times
Mr. Farley’s salary then in effect as of the date of termination, less applicable taxes and withholdings; (ii) provide reimbursement
to Mr. Farley’s medical insurance premiums for a period of twelve (12) months following the date of termination; and (iii) notwithstanding
any provision of any stock incentive plan, stock option agreement, realization bonus, restricted stock agreement or other agreement relating
to capital stock of the Company, cause any equity awards granted prior to that are then outstanding and unvested to immediately vest
and, with respect to all options and stock appreciation rights, to become fully exercisable (but not later than when the award would
otherwise expire).
The Farley Employment
Agreement also contains customary non-solicitation and non-competition covenants, which covenants remain in effect for twelve (12) months
following any cessation of employment with respect to Mr. Farley. To the extent any of the payments or benefits provided for under the
Farley Employment Agreement or any other agreement or arrangement between Mr. Farley and the Company (collectively, the “Payments”),
(a) constitute an “excess parachute payment” within the meaning of Section 280G (“Section 280G”) of the Internal
Revenue Code of 1986, as amended and restated (the “Code”), and (b) would otherwise be subject to the excise tax imposed
by Section 4999 of the Code (“Section 4999”), then the Company will pay or provide the greater (whichever gives Mr. Farley
the highest net after-tax amount) of (i) all of the Payments or (ii) the portion of Payments not in excess of the greatest amount of
Payments that can be paid that would not result in the imposition of the excise tax under Section 4999.
66
Shahrokh Shabahang, Chief Innovation Officer
On November 14, 2021, the
Company entered into a new employment agreement (the “Shabahang Employment Agreement”) with the Company’s Chief Innovation
Officer, Shahrokh Shabahang, pursuant to which Mr. Shabahang will continue to serve as the Company’s Chief Innovation Officer until
the date upon which Mr. Shabahang’s employment may be terminated in accordance with the terms of the Shabahang Employment Agreement.
The term of Mr. Shabahang’s
engagement under the Shabahang Employment Agreement commences as of the Effective Date (as defined in the Shabahang Employment Agreement)
and continues until November 14, 2023, unless earlier terminated in accordance with the terms of the Shabahang Employment Agreement.
The term of Mr. Shabahang’s Employment Agreement is automatically renewed for successive one (1) year periods until terminated
by Mr. Shabahang or the Company.
Pursuant to the Shabahang
Employment Agreement, Mr. Shabahang will receive: (i) a base salary at the annual rate of $210,000 for the remainder of calendar year
2021, and effective January 1, 2022, $325,000 (prorated for any partial year) payable in bimonthly installments, and (ii) eligible to
earn an annual discretionary bonus with a target amount of 40% of Base Compensation, which is based on the achievement of performance
objectives, which will be determined by the Board and Compensation Committee. In addition, for calendar year 2021, Mr. Shabahang will
be eligible to earn an additional discretionary bonus as determined by the Company.
Under the Shabahang Employment
Agreement, termination of Mr. Shabahang by the Company for “Cause,” “Death,” or “Disability,” (as
such terms are defined in the Shabahang Employment Agreement), or resignation by Mr. Shabahang without “Good Reason” (as
defined in the Shabahang Employment Agreement), will not require the Company to pay severance to Mr. Shabahang. Upon any such termination,
Mr. Shabahang will be entitled to receive any Accrued Compensation (as defined in the Shabahang Employment Agreement), which in the case
of termination by the Company for Cause or resignation by Mr. Shabahang for Good Reason will not include payment of pro rata bonus; provided , however ,
if termination of Mr. Shabahang by the Company without “Cause” or resignation by Mr. Shabahang for “Good Reason,”
then under the Shabahang Employment Agreement will require the Company to pay severance to Mr. Shabahang. Upon any such termination,
Mr. Shabahang will be entitled to receive any Accrued Compensation and, subject to Mr. Shabahang’s execution of an irrevocable
release, receive: (i) on the sixtieth day (60th) day following termination, a lump sum cash-payment equal to the sum of (A) the product
of two times Mr. Shabahangs’s salary then in effect as of the date of termination, less applicable taxes and withholdings, and
(B) the product of two times Mr. Shabahang’s Target Bonus (as defined in the Shabahang Employment Agreement); (ii) provide reimbursement
to Mr. Shabahang’s medical insurance premiums for a period of twelve (12) months following the date of termination; and (iii) cause
any equity awards granted prior to the Effective Date (as defined in the Shabahang Employment Agreement), that are then outstanding and
unvested to immediately vest and, with respect to all options and stock appreciation rights, to become fully exercisable.
Notwithstanding the foregoing,
under the Shabahang Employment Agreement, termination of Mr. Shabahang by the Company without Cause or resignation by Mr. Shabahang for
Good Reason and a Change of Control (as defined in the Shabahang Employment Agreement) of the Company occurs within six (6) months after
such termination, or within twenty-four (24) months prior to such termination, the Company will pay severance to Mr. Shabahang in connection
to such termination. Upon such termination, Mr. Shabahang will be entitled to receive any Accrued Compensation, and subject to Mr. Shabahang’s
execution of an irrevocable release, receive: (i) on the sixtieth (60th) day of termination, a lump sum cash-payment equal to the product
of two times Mr. Shabahang’s salary then in effect as of the date of termination, less applicable taxes and withholdings; (ii)
provide reimbursement to Mr. Shabahang’s medical insurance premiums for a period of twenty-four (24) months following the date
of termination; and (iii) notwithstanding any provision of any stock incentive plan, stock option agreement, realization bonus, restricted
stock agreement or other agreement relating to capital stock of the Company, cause any equity awards granted prior to that are then outstanding
and unvested to immediately vest and, with respect to all options and stock appreciation rights, to become fully exercisable for twenty-four
(24) months (but not later than when the award would otherwise expire).
The Shabahang
Employment Agreement also contains customary non-solicitation and non-competition covenants, which covenants remain in effect for twelve
(12) months following any cessation of employment with respect to Mr. Shabahang. To the extent any of the payments or benefits provided
for under the Shabahang Employment Agreement or any other agreement or arrangement between Mr. Shabahang and the Company (collectively,
the “Payments”), (a) constitute an “excess parachute payment” within the meaning of Section 280G (“Section
280G”) of the Internal Revenue Code of 1986, as amended and restated (the “Code”), and (b) would otherwise be subject
to the excise tax imposed by Section 4999 of the Code (“Section 4999”), then the Company will pay or provide the greater
(whichever gives Mr. Shabahang the highest net after-tax amount) of (i) all of the Payments or (ii) the portion of Payments not in excess
of the greatest amount of Payments that can be paid that would not result in the imposition of the excise tax under Section 4999.
Rowena Albanna, Chief Operating Officer
On November 14, 2021, the
Company entered into a new employment agreement (the “Rowena Employment Agreement”) with the Company’s Chief Operating
Officer, Rowena Albanna, pursuant to which Ms. Albanna will continue to serve as the Company’s Chief Operating Officer until the
date upon which Ms. Albanna’s employment may be terminated in accordance with the terms of the Rowena Employment Agreement.
67
The term of Ms. Albanna’s
engagement under the Rowena Employment Agreement commences as of the Effective Date (as defined in the Rowena Employment Agreement) and
continues until November 14, 2023, unless earlier terminated in accordance with the terms of the Rowena Employment Agreement. The term
of Ms. Albanna’s Employment Agreement is automatically renewed for successive one (1) year periods until terminated by Ms. Albanna
or the Company.
Pursuant to the
Rowena Employment Agreement, Ms. Albanna will receive: (i) a base salary at the annual rate of $210,000 for the remainder of calendar
year 2021 and effective January 1, 2022, $325,000 (prorated for any partial year) payable in bimonthly installments, and (ii) eligible
to earn an annual discretionary bonus with a target amount of 40% of Base Compensation, which is based on the achievement of performance
objectives, which will be determined by the Board and Compensation Committee. In addition, for calendar year 2021, Ms. Albanna will be
eligible to earn an additional discretionary bonus as determined by the Company.
Under the Rowena Employment
Agreement, termination of Ms. Albanna by the Company for “Cause,” “Death,” or “Disability,” (as such
terms are defined in the Rowena Employment Agreement), or resignation by Ms. Albanna for “Good Reason” (as defined in the
Rowena Employment Agreement), will not require the Company to pay severance to Ms. Albanna. Upon any such termination, Ms. Albanna will
be entitled to receive any Accrued Compensation (as defined in the Rowena Employment Agreement), which in the case of termination by
the Company for Cause or resignation by Ms. Albanna for Good Reason will not include payment of pro rata bonus; provided , however ,
if termination of Ms. Albanna by the Company without “Cause” or resignation by Ms. Albanna for “Good Reason”
(as such terms are defined in the Rowena Employment Agreement), then under the Rowena Employment Agreement will require the Company to
pay severance to Ms. Albanna. Upon any such termination, Ms. Albanna will be entitled to receive any Accrued Compensation and, subject
to Ms. Albanna’s execution of an irrevocable release, receive: (i) on the sixtieth day (60th) day following termination, a lump
sum amount equal to twelve (12) months base salary then in effect as of the date of termination, less applicable taxes and withholdings;
(ii) provide reimbursement to Ms. Albanna’s medical insurance premiums for a period of twelve (12) months following the date of
termination; and (iii) cause any equity awards granted prior to the Effective Date (as defined in the Rowena Employment Agreement), that
are then outstanding and unvested to immediately vest and, with respect to all options and stock appreciation rights, to become fully
exercisable.
Notwithstanding the foregoing,
under the Rowena Employment Agreement, termination of Ms. Albanna by the Company without Cause or resignation by Ms. Albanna for Good
Reason and a Change of Control (as defined in the Rowena Employment Agreement) of the Company occurs within six (6) months after such
termination, or within twenty-four (24) months prior to such termination, the Company will pay severance to Ms. Albanna in connection
to such termination. Upon such termination, Ms. Albanna will be entitled to receive any Accrued Compensation, and subject to Ms. Albanna’s
execution of an irrevocable release, receive: (i) on the sixtieth (60th) day of termination, a lump sum cash-payment equal to the sum
of (A) the product of two times Ms. Albanna’s salary then in effect as of the date of termination, less applicable taxes and withholdings,
and (B) the product of two times Ms. Albanna’s Target Bonus; (ii) provide reimbursement to Ms. Albanna’s medical insurance
premiums for a period of twenty-four (24) months following the date of termination; and (iii) notwithstanding any provision of any stock
incentive plan, stock option agreement, realization bonus, restricted stock agreement or other agreement relating to capital stock of
the Company, cause any equity awards granted prior to the that are then outstanding and unvested to immediately vest and, with respect
to all options and stock appreciation rights, to become fully exercisable for twenty-four (24) months (but not later than when the award
would otherwise expire).
The Rowena Employment
Agreement also contains customary non-solicitation and non-competition covenants, which covenants remain in effect for twelve (12) months
following any cessation of employment with respect to Ms. Albanna. To the extent any of the payments or benefits provided for under the
Rowena Employment Agreement or any other agreement or arrangement between Ms. Albanna and the Company (collectively, the “Payments”),
(a) constitute an “excess parachute payment” within the meaning of Section 280G (“Section 280G”) of the Internal
Revenue Code of 1986, as amended and restated (the “Code”), and (b) would otherwise be subject to the excise tax imposed
by Section 4999 of the Code (“Section 4999”), then the Company will pay or provide the greater (whichever gives Ms. Albanna
the highest net after-tax amount) of (i) all of the Payments or (ii) the portion of Payments not in excess of the greatest amount of
Payments that can be paid that would not result in the imposition of the excise tax under Section 4999.
Christopher J. Porcelli, General Counsel, Chief People Officer
and Corporate Secretary
On September 30, 2025, the Company entered into an offer letter (the
“Porcelli Letter”) with the Company’s General Counsel, Chief People Officer and Corporate Secretary, Christopher J.
Porcelli, to serve as General Counsel, Chief People Officer and Corporate Secretary of the Company, effective September 30, 2025. The
offer letter provides for, among other things, (i) an annual base salary of $350,000, (ii) at-will employment and eligibility to participate
in the Company’s employee benefit plans generally available to senior executives, and (iii) an initial equity award under the Company’s
equity incentive plan, subject to approval by the Compensation Committee, which is expected to vest over three years, subject to continued
service. The Porcelli Letter is filed herewith as Exhibit 10.212.
68
Item 12. Security Ownership of Certain
Beneficial Owners and Management and Related Stockholder Matters
The following table sets
forth certain information regarding beneficial ownership of shares of our common stock as of March 31, 2026 (i) each person known to
beneficially own more than 5% of our outstanding common stock, (ii) each of our directors, (iii) our executive officers and (iv) all
directors and executive officers as a group. Shares are beneficially owned when an individual has voting and/or investment power over
the shares or could obtain voting and/or investment power over the shares within 60 days of March 31, 2026. Except as otherwise indicated,
the persons named in the table have sole voting and investment power with respect to all shares beneficially owned, subject to community
property laws, where applicable. Unless otherwise indicated, the address of each beneficial owner listed below is c/o Aditxt, Inc., 2569
Wyandotte Street, Suite 101, Mountain View, CA 94043.
Number
of
shares of
Common
Stock
Beneficially
Owned
Percentage
Directors and Officers:
Amro Albanna (1)
3
*
%
Shahrokh Shabahang, D.D.S., MS, Ph.D. (2)
7
*
%
Corinne Pankovcin (3)
1
*
%
Rowena Albanna (4)
2
*
%
Brian Brady (5)
4
*
%
Thomas J. Farley (6)
2
*
%
Charles Nelson (7)
2
*
%
Sylvia Hermina
-
*
%
Christopher Porcelli
-
*
%
All directors and executive officers as a group
(9 persons)
21
*
%
*
Less than 1%
(1)
Includes (i) 1 shares issuable
pursuant to options that are fully vested; (ii) 1 share beneficially owned by the Albanna Family Trust, of which Mr. Albanna is the
Trustee and (iii) 1 share directly owned by Mr. Albanna;. Mr. Albanna may be deemed to beneficially own the securities held by his
wife Rowena Albanna, the Company’s Chief Operating Officer.
(2)
Includes (i) 1 shares issuable pursuant to options that are fully vested; (ii) 4 shares beneficially owned by the Shabahang-Hatami Family Trust of which Shahrokh Shabahang, D.D.S., MS, Ph.D. is the Trustee and (iii) 2 shares directly owned by Mr. Shabahang.
(3)
Includes 1 shares issuable
pursuant to options that are fully vested.
(4)
Includes (i) 1 shares held
directly by Ms. Albanna and (ii) 1 shares issuable pursuant to options that are fully vested. Ms. Albanna may be deemed to beneficially
own the securities held by her husband Amro Albanna, the Company’s Chief Executive Officer.
(5)
Includes(i) 3 shares held directly by Mr. Brady; and (ii) 1 share issuable pursuant to options that are fully vested.
(6)
Includes(i) 1 share held
directly by Mr. Farley and (ii) 1 shares issuable pursuant to options that are fully vested.
(7)
Includes(i) 1 share held
by Siu Kim Athle International, LLC., over which Mr. Nelson has voting and dispositive control and (ii) 1 share issuable pursuant
to options that are fully vested.
Item 13. Certain Relationships and Related
Transactions, and Director Independence
Except as described below
and except for employment arrangements which are described under “executive compensation,” during our fiscal years ended
December 31, 2025 and December 31, 2024, there has not been, nor is there currently proposed, other than described below, any transaction
in which we are or were a participant, the amount involved exceeds the lesser of $120,000 or 1% of the average of the total assets at
December 31, 2025 and 2024, and any of our directors, executive officers, holders of more than 5% of our Common Stock or any immediate
family member of any of the foregoing had or will have a direct or indirect material interest.
On May 22, 2025 Amro Albanna,
the Chief Executive Officer of the Company, loaned $233,000 to the Company. The loan was evidenced by an unsecured promissory note (the
“May 22nd Note”). Pursuant to the terms of the May 22nd Note, it will accrue interest at the Prime rate of seven and one-half
percent (7.5%) per annum and is due on the earlier of November 22, 2025 or an event of default, as defined therein. As of December 31,
2025, the May 22nd Note was fully paid off.
69
On February 15, 2024, Amro
Albanna, the Chief Executive Officer of the Company loaned $205,000 to the Company. The loan was evidenced by an unsecured promissory
note (the “February 15 th Note”). Pursuant to the terms of the February Note, it will accrue interest at the Prime
rate of eight and one-half percent (8.5%) per annum and is due on the earlier of August 15, 2024 or an event of default, as defined therein.
As of December 31, 2025, the February 15 th Note was fully paid off.
Review, Approval and Ratification of Related
Party Transactions
Given our small size and
limited financial resources, we have not adopted formal policies and procedures for the review, approval or ratification of transactions,
such as those described above, with our executive officer(s), Director(s) and significant stockholders. We intend to establish formal
policies and procedures in the future, once we have sufficient resources and have appointed additional Directors, so that such transactions
will be subject to the review, approval or ratification of our Board of Directors, or an appropriate committee thereof. On a moving forward
basis, our Directors will continue to approve any related party transaction.
Item 14. Principal Accounting Fees and
Services
dbbmckennon acted as the
Company’s independent registered public accounting firm for the years ended December 31, 2025 and 2024 and for the interim periods
in such fiscal years. The following table shows the fees that were incurred by the Company for audit and other services provided by dbbmckennon
for the years ended December 31, 2025 and 2024.
Year
Ended
December 31,
2025
Year
Ended
December 31,
2024
Audit Fees (a)
$ 247,203
$ 122,753
Tax Fees (b)
-
-
Other Fees (c)
20,000
53,250
Total
$ 267,203
$ 176,003
(a)
Audit fees represent fees
for professional services provided in connection with the audit of the Company’s annual financial statements and the review
of its financial statements included in the Company’s Quarterly Reports on Form 10-Q and services that are normally
provided in connection with statutory or regulatory filings.
(b)
Tax fees represent fees
for professional services related to tax compliance, tax advice and tax planning.
(c)
Other fees represent fees
related to our filing of certain Registration Statements.
70
PART IV
Item 15. Exhibits, Financial Statement Schedules.
(a) The
following documents are filed as part of this report:
(1) Financial
Statements:
Report of Independent Registered Public Accounting Firm
F-2
Consolidated Balance Sheets
F-3
Consolidated Statements of Operations
F-4
Consolidated
Statements of Changes in Stockholders’ Equity
F-5
Consolidated Statements of Cash Flows
F-7
Notes to Consolidated Financial Statements
F-8
(2) Financial
Statement Schedules:
All financial statement schedules
have been omitted because they are not applicable, not required or the information required is shown in the financial statements or the
notes thereto.
71
(3) Exhibits.
EXHIBIT INDEX
Exhibit No.
Description
1.1
At The Market Offering Agreement dated December 20, 2022 between Aditxt, Inc. and H.C. Wainwright & Co., LLC (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 20, 2022)
2.1
Share Exchange Agreement, dated as of December 28, 2021 by and between AiPharma Group Ltd. and Aditxt, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 28, 2021)
2.2
Amendment to Share Exchange Agreement by and between AiPharma Group Ltd. and Aditxt, Inc. (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on May 16, 2022)
2.3
Second Amendment to Share Exchange Agreement by and between AiPharma Group Ltd. and Aditxt, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 16, 2022)
2.4
Arrangement Agreement between Appili Therapeutics, Inc., Aditxt, Inc. and Adivir, Inc. dated as of April 1, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 4, 2024)
2.5
Amending Agreement between Appili Therapeutics, Inc., Aditxt, Inc. and Adivir, Inc. dated as of July 1, 2024(incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 8, 2024)
2.6
Second Amending Agreement between Appili Therapeutics, Inc., Aditxt, Inc. and Adivir, Inc. dated as of July 1, 2024(incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 22, 2024)
2.7
Third Amending Agreement between Appili Therapeutics, Inc., Aditxt, Inc. and Adivir, Inc. dated as of August 20, 2024(incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 21, 2024)
3.1
Amended and Restated Certificate of Incorporation (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
3.2
Certificate of Amendment, dated June 29, 2020 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020)
3.3
Amended and Restated Bylaws (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
3.4
Certificate of Designation Series A Preferred Stock (incorporated by reference to the Registrant’s Registration Statement on Form S-1 (File No. 333-248491)
3.5
Certificate of Amendment, filed with the Secretary of State of the State of Delaware on May 24, 2021 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 25, 2021)
3.6
Certificate of Amendment, dated July 6, 2021 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 8, 2021)
3.7
Amendment No. 1 to Amended and Restated Bylaws of Aditxt, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 8, 2022)
3.8
Certificate of Designation of Series B Preferred Stock, dated July 19, 2022 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 20, 2022)
3.9
Certificate of Amendment to Certificate of Incorporation of Aditxt, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on September 14, 2022)
3.10
Certificate of Designation for Series A-1 Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 26, 2023)
3.11
Certificate of Designation for Series B-1 Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 30, 2024)
3.12
Certificate of Designation for Series B-2 Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 2, 2024)
3.13
Certificate of Designation for Series C-1 Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 8, 2024)
3.14
Certificate of Designation for Series D-1 Preferred Stock (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 8, 2024)
3.15
Certificate of Amendment to Certificate of Incorporation filed and effective with the Delaware Secretary of State on August 8, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 8, 2024)
3.16
Certificate of Amendment to Certificate of Incorporation of Aditxt, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 3, 2024)
3.17
Certificate of Amendment to Certificate of Incorporation of Aditxt, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on March 12, 2025)
3.18
Certificate of Amendment to Certificate of Incorporation of Aditxt, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 31, 2025)
72
4.1
Description of Securities Registered Under Section 12 of the Exchange Act (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 25, 2021)
4.2
Form the Company’s common stock certificate (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
4.3
Form of Series A-1 Warrant Agent Agreement (including the terms of the Series A-1 Warrant) (incorporated by reference to the Registrant’s Registration Statement on Form S-1 (File No. 333-248491)
4.4
Form of Series B-1 Warrant Agent Agreement (including the terms of the Series B-1 Warrant) (incorporated by reference to the Registrant’s Registration Statement on Form S-1 (File No. 333-248491)
4.5
Form of Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 30, 2021)
4.6
Form of Warrant (July 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 9, 2024)
4.7
Form of Amendment to Common Stock Purchase Warrants (July 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 9, 2024)
4.8
Form of Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 18, 2024)
4.9
Form of Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 8, 2024)
4.10
Form of Pre-Funded Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 9, 2024)
4.11
Form of Placement Agent Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 9, 2024)
4.12
Form of Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 25, 2025)
10.1
Form of Promissory Note issued to Sekris Biomedical, Inc. (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.2
Warrant, dated March 8, 2018, issued to Sekris Biomedical, Inc. (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.3
Form of Private Placement Subscription Agreement (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.4
Patent Licensing Agreement, dated February 3, 2020 (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.5
Patent and Technology License Agreement, dated March 15, 2018 between Loma Linda University and Aditx Therapeutics, Inc. (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.6
Amendment Agreement to the Patent and Technology License Agreement, dated July 1, 2020 by and between Loma Linda University and Aditx Therapeutics, Inc. (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on August 13, 2020)
10.7
2017 Equity Incentive Plan and forms of award agreements thereunder (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
73
10.8
Consulting Agreement, dated March 1, 2018 between Aditx Therapeutics, Inc. and Canyon Ridge Development LLC d/b/a Mission Critical Solutions International (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.9
Form of July 2018 Securities Purchase Agreement (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.10
Form of July 2018 Note (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.11
Form of April 2018 Promissory Note (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.12
Form of March 2019 Promissory Note (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.13
Form of October 2019 Securities Purchase Agreement (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.14
Form of October 2019 Note (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.15
Form of January 2020 Note Purchase Agreement (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.16
Form of January 2020 Private Placement Promissory Note (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A (File No. 333-235933)
10.17
Consulting Agreement by and between the Company and Salveo Diagnostics, Inc., dated November 18, 2020 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on November 23, 2020)
10.18
Form of Senior Secured Convertible Promissory Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 26, 2021)
10.19
Form of Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 26, 2021)
10.20
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 26, 2021)
10.21
Form of Registration Rights Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 26, 2021)
10.22
Employment Agreement, dated as of February 24, 2021, by and between the Company and Amro Albanna (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 26, 2021)
10.23
2021 Omnibus Equity Incentive Plan (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 26, 2021)
10.24
Lease Agreement, dated as of May 4, 2021, by and between LS Biotech Eight, LLC as Landlord, and Aditxt Therapeutics, Inc., as Tenant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 10, 2021)
10.25
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 30, 2021)
10.26
Placement Agency Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 30, 2021)
10.27
Form of Placement Agent Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 30, 2021)
10.28
Waiver and Defeasance Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 30, 2021)
10.29
Secured Credit Agreement, dated as of August 27, 2021, by and among AiPharma, AiPharma Holdings Limited, AiPharma Asia Limited and the Company (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.30
Security Agreement, dated as of August 27, 2021 by and between AiPharma Asia Limited and the Company (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.31
Security Agreement, dated as of August 27, 2021 by and between AiPharma Limited and the Company (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.32
Security Agreement – AiPharma Limited and Aditxt (BVI Law) (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
74
10.33
Floating Charge (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.34
Transaction Agreement, dated as of October 4, 2021, by and between the Company and AiPharma Global Holdings LLC (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.35
First Amendment to Secured Credit Agreement with AiPharma Global Holdings LLC dated October 18, 2021 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.36
Second Amendment to Secured Credit Agreement with AiPharma Global Holdings LLC dated October 27, 2021(incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.37
Employment Agreement, dated as of November 14, 2021 between Aditxt, Inc. and Amro Albanna, Chief Executive Officer (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.38
Employment Agreement, dated as of November 14, 2021 between Aditxt, Inc. and Corinne Pankovcin, President and Secretary (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.39
Employment Agreement, dated as of November 14, 2021 between Aditxt, Inc. and Thomas Farley, Chief Financial Officer (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.40
Employment Agreement, dated as of November 14, 2021 between Aditxt, Inc. and Shahrokh Shabahang, Chief Innovation Officer (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.41
Employment Agreement, dated as of November 14, 2021 between Aditxt, Inc. and Rowena Albanna, Chief Operating Officer (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on November 15, 2021)
10.42
Form of Warrant Reduction and Release Agreement dated as of November 24, 2021 (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.43
First Amendment to Transaction Agreement dated November 30, 2021, by and between the Company and AiPharma Global Holdings LLC (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.44
Third Amendment to Secured Credit Agreement dated November 30, 2021, by and among AiPharma, AiPharma Holdings Limited, AiPharma Asia Limited and the Company (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.45
Second Amendment to Transaction Agreement dated December 7, 2021, by and between the Company and AiPharma Global Holdings LLC (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.46
Secured Credit Agreement, dated as of December 8, 2021, by and among the Company and the Target Company (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.47
Third Amendment to Transaction Agreement dated December 17, 2021, by and between the Company and AiPharma Global Holdings LLC (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.48
Fifth Amendment to Secured Credit Agreement dated December 22, 2021, by and among AiPharma, AiPharma Holdings Limited, AiPharma Asia Limited and the Company (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.49
Sixth Amendment to Secured Credit Agreement dated December 28, 2021, by and among AiPharma, AiPharma Holdings Limited, AiPharma Asia Limited and the Company (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.50
Employment Agreement between Aditxt, Inc. and Matthew Shatzkes, Chief Legal Officer and General Counsel (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.51
Forbearance Agreement and Seventh Amendment to Secured Credit Agreement dated as of February 14, 2022 by and among the Company, Cellvera Global Holdings LLC, Cellvera Holdings Ltd., Cellvera Asia Limited (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
75
10.52
Fourth Amendment to Transaction Agreement dated December 22,2021, by and between the Company and AiPharma Global Holdings LLC (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.53
Series C Warrant Agent Agreement (incorporated by reference to the Registrant’s Annual Report on Form 10-K/A filed on April 15, 2022)
10.54
Form of Placement Agent Warrant dated January 25, 2021 (incorporated by reference to the Registrant’s Annual Report on Form 10-K/A filed on April 15, 2022)
10.55
Forbearance Agreement and Eighth Amendment to Secured Credit Agreement dated as of March 31, 2022 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on May 16, 2022)
10.56
Security Agreement between Cellvera Holdings and Aditxt, Inc. dated as of March 31, 2022 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on May 16, 2022)
10.57
Security Agreement between Cellvera Development LLC and Aditxt, Inc. dated as of March 31, 2022 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on May 16, 2022)
10.58
Security Agreement between Cellvera Global Holdings and Aditxt, Inc. dated as of March 31, 2022 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on May 16, 2022)
10.59
Amended and Restated Security Agreement between Cellvera Asia Limited and Aditxt, Inc. dated as of March 31, 2022 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on May 16, 2022)
10.60
Revenue Sharing Agreement by and among Aditxt, Inc., Cellvera Global Holdings LLC and Cellvera Asia Limited dated as of March 31, 2022 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on May 16, 2022)
10.61
Form of Agreement for the Purchase and Sale of Future Receipts (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 3, 2022)
10.62
Amendment No. 1 to Series C Warrant Agent Agreement dated June 15, 2022 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 15, 2022)
10.63
Inducement Offer to Exercise Series C Common Stock Purchase Warrants (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 15, 2022)
10.64
Form of New Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 15, 2022)
10.65
Form of Placement Agent Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 15, 2022)
10.66
Subscription and Investment Representation Agreement, dated July 19, 2022 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 20, 2022)
10.67
Unsecured Promissory Note dated July 21, 2022 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 26, 2022)
10.68
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 10, 2022)
10.69
Form of August 2022 Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 10, 2022)
10.70
Form of August 2022 Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 10, 2022)
10.71
Form of Registration Rights Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 10, 2022)
10.72
Form of Security Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 10, 2022)
10.73
Form of First Amendment and Waiver effective as of August 31, 2022 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on September 7, 2022)
10.74
Form of Warrant (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on September 7, 2022)
10.75
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Registration Statement on Form S-1 filed on September 15, 2022)
10.76
Form of Warrant (incorporated by reference to the Registrant’s Registration Statement on Form S-1 filed on September 15, 2022)
10.77
Form of Placement Agent’s Warrant (incorporated by reference to the Registrant’s Registration Statement on Form S-1 filed on September 15, 2022)
10.78
Form of Pre-Funded Warrant (incorporated by reference to the Registrant’s Registration Statement on Form S-1 filed on September 15, 2022)
76
10.79
Amendment No. 2 to Series C Warrant Agent Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 23, 2022)
10.80
Form of Amended and Restated Unit Purchase Option (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 23, 2022)
10.81
Form of Consulting Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on March 21, 2023)
10.82
Form of Business Loan and Security Agreement dated April 4, 2023(incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 7, 2023)
10.83
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 24, 2023)
10.84
Form of Unsecured Promissory Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 25, 2023)
10.85
Form of Business Loan and Security Agreement, dated April 24, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 25, 2023)
10.86
Form of Agreement for the Purchase and Sale of Future Receipts (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 31, 2023)
10.87
Unsecured Promissory Note dated May 25, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 31, 2023)
10.88
Form of Unsecured Promissory Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 16, 2023)
10.89
At The Market Offering Agreement dated December 20, 2022 between Aditxt, Inc. and H.C. Wainwright & Co., LLC (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 20, 2022)
10.90
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 7, 2023)
10.91
Form of Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 7, 2023)
10.92
Form of Security Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 7, 2023)
10.93
Form of Registration Rights Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 7, 2023)
10.94
Form of Business Loan and Security Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 7, 2023)
10.95
Subscription and Investment Representation Agreement, dated July 11, 2023, by and between Aditxt, Inc., and the purchaser signatory thereto (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 14, 2023)
10.96
Separation Agreement and General Release by and between Matthew Shatzkes and Aditxt, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 27, 2023)
10.97
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 28, 2023)
10.98
Form of Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 28, 2023)
10.99
Form of Security Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 28, 2023)
10.100
Form of Registration Rights Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 28, 2023)
10.101
Amendment to Separation Agreement and General Release dated August 15, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 21, 2023)
10.102
Form of Business Loan and Security Agreement dated August 23, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 28, 2023)
10.103
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on September 6, 2023)
10.104
Form of Registration Rights Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on September 6, 2023)
77
10.105
Form of Business Loan and Security Agreement dated November 7, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on November 9, 2023)
10.106
Form of Unsecured Promissory Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 1, 2023)
10.107
Form of Unsecured Promissory Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 8, 2023)
10.108
Assignment Agreement dated as of December 11, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 12, 2023)
10.109
Form of December 2023 Secured Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 12, 2023)
10.110
Form of September 2024 Secured Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 12, 2023)
10.111
Form of Royalty Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 12, 2023)
10.112
IP Security Agreement dated December 11, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 12, 2023)
10.113
Security Agreement dated December 11, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 12, 2023)
10.114
Form of Consulting Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 22, 2023)
10.115
Form of Unsecured Promissory Note dated December 20, 2023 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 22, 2023)
10.116
Exchange Agreement, dated December 22, 2023 by and between the Company and the holders signatory thereto (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 26, 2023)
10.117
Registration Rights Agreement, dated December 22, 2023 by and between the Company and the holders signatory thereto (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on December 26, 2023)
10.118
Exchange Agreement, dated December 28, 2023 by and between the Company and the holders signatory thereto (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 2, 2024)
10.119
Form of Voting Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 2, 2024)
10.120
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 5, 2024)
10.121
Form of Registration Rights Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 5, 2024)
10.122
Form of Amendment No. 1 to January 2024 Secured Notes (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 5, 2024)
10.123
Form of Amendment No. 2 to January 2024 Secured Notes (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 5, 2024)
10.124
Form of Amendment No. 1 to September 2024 Secured Notes (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 5, 2024)
10.125
First Amendment to Asset Purchase Agreement dated January 4, 2024 by and among Aditxt, Inc., Pearsanta, Inc. and MDNA Life Sciences, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 9, 2024)
10.126
First Amendment to Agreement and Plan of Merger dated as of January 8, 2024, by and among Aditxt, Inc., Adicure, Inc. and Evofem Biosciences, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 9, 2024)
10.127
Form of Business Loan and Security Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 30, 2024)
10.128
Assignment Agreement dated January 24, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 30, 2024)
10.129
Form of Securities Purchase Agreement dated January 24, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 30, 2024)
78
10.130
Patent Assignment dated January 24, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 30, 2024)
10.131
Form of Voting Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on January 30, 2024)
10.132
Second Amendment to Agreement and Plan of Merger dated as of January 8, 2024, by and among Aditxt, Inc., Adicure, Inc. and Evofem Biosciences, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 2, 2024)
10.133
Form of Amendment No. 3 to January 2024 Secured Notes (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 6, 2024)
10.144
Form of Amendment No. 2 to September 2024 Secured Notes (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 6, 2024)
10.145
Form of Unsecured Promissory Note dated February 7, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 9, 2024)
10.146
Unsecured Promissory Note dated February 15, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 16, 2024)
10.147
Engagement Letter dated February 16, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 21, 2024)
10.148
Assignment Agreement dated as of February 26, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 29, 2024)
10.149
Form of Amendment No. 4 to January 2024 Secured Notes (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 29, 2024)
10.150
Payoff Letter dated February 26, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 29, 2024)
10.151
Form of Unsecured Promissory Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on March 1, 2024)
10.152
Third Amendment to Agreement and Plan of Merger dated as of February 29, 2024, by and among Aditxt, Inc., Adicure, Inc. and Evofem Biosciences, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on March 4, 2024)
10.153
Unsecured Promissory Note dated March 7, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on March 11, 2024)
10.154
Unsecured Promissory Note dated April 10, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 12, 2024)
10.155
Reinstatement and Fourth Amendment to the Merger Agreement dated May 2, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K/A filed on May 3, 2024)
10.156
Common Stock Purchase Agreement dated as of May 2, 2024 by and among Aditxt, Inc. and the Investor (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 7, 2024)
10.157
Registration Rights Agreement dated as of May 2, 2024 by and between the Investor and Aditxt, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 7, 2024)
10.158
Form of Securities Purchase Agreement dated as of May 2, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 8, 2024)
79
10.159
Form of Registration Rights Agreement dated as of May 2, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 8, 2024)
10.160
Unsecured Promissory Note dated May 9, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 13, 2024)
10.161
Form of Senior Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 22, 2024)
10.162
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 28, 2024)
10.163
Form of Senior Note (May 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 28, 2024)
10.164
Unsecured Promissory Note dated June 20, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 25, 2024)
10.165
Form of Securities Purchase Agreement (July 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 9, 2024)
10.166
Form of Senior Note (July 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 9, 2024)
10.167
Amended and Restated Agreement and Plan of Merger among Aditxt, Inc., Adifem, Inc. f/k/a Adicure, Inc. and Evofem Biosciences, Inc. dated as of July 12, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 18, 2024)
10.168
Waiver Agreement by and between Evofem Biosciences, Inc., Aditxt, Inc. and Adifem, Inc. dated July 12, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 18, 2024)
10.169
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 18, 2024)
10.170
Form of Senior Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 18, 2024)
10.171
Securities Purchase Agreement by and among Evofem Biosciences, Inc. and Aditxt, Inc. dated July 12, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 18, 2024)
10.172
Registration Rights Agreement by and among Evofem Biosciences, Inc. and Aditxt, Inc. dated July 12, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 18, 2024)
10.173
Exchange Agreement dated August 7, 2024 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 8, 2024)
10.174
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 9, 2024)
10.175
Form of Lock-Up Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 9, 2024)
10.176
Form of Securities Purchase Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 13, 2024)
10.177
Form of Registration Rights Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 13, 2024)
10.178
Amendment No. 1 to Amended and Restated Merger Agreement (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q filed on August 19, 2024)
10.179
Form of Waiver to Senior Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 28, 2024)
10.180
Form of Letter Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on August 28, 2024)
10.181
Amendment No. 2 to Amended and Restated Agreement and Plan of Merger dated as of September 6, 2024, by and among Aditxt, Inc., Adifem, Inc. and Evofem Biosciences, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on September 6, 2024)
10.182
Form of Senior Note (September 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on September 23, 2024)
80
10.183
Form of Securities Purchase Agreement (September 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on September 23, 2024)
10.184
Form of Registration Rights Agreement (September 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on September 23, 2024)
10.185
Market Development and Collaboration Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on September 23, 2024)
10.186
Amendment No. 3 to Amended and Restated Merger Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 3, 2024)
10.187
Form of Securities Purchase Agreement (Oct 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 3, 2024)
10.188
Form of Registration Rights Agreement (Oct 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 3, 2024)
10.189
Form of Securities Purchase Agreement (Oct 28, 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 30, 2024)
10.190
Form of Registration Rights Agreement (Oct 28, 2024) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on October 30, 2024)
10.191
Amendment No. 4 to Amended and Restated Merger Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on November 19, 2024)
10.192
Settlement Agreement dated March 5, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on March 6, 2025)
10.193
Form of Promissory Note (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on March 6, 2025)
10.194
Amendment No. 5 to Amended and Restated Merger Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on March 24, 2025)
10.195
Securities Purchase Agreement by and between Evofem Biosciences, Inc. and Aditxt, Inc. dated April 9, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 9, 2025)
10.196
Form of Senior Subordinated Convertible Note of Evofem Biosciences, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 9, 2025)
10.197
Form of Warrant of Evofem Biosciences, Inc. (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 9, 2025)
10.198
Waiver Agreement by and between Evofem Biosciences, Inc., Aditxt, Inc. and Adifem, Inc. dated April 8, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 9, 2025)
10.199
Call Option Agreement by and among Aditxt, Inc., Adjuvant Global Health Technology Fund, L.P. and Adjuvant Global Health Technology fund DE, L.P., and Evofem Biosciences, Inc. dated April 10, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 15, 2025)
10.200
Form of Senior Note (April 2025) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on April 25, 2025)
10.201
Securities Purchase Agreement dated May 9, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 15, 2025)
81
10.202
Senior Secured Note, dated May 9, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 15, 2025)
10.203
Form of Forbearance Agreement (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 15, 2025)
10.204
Unsecured Promissory Note dated May 22, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on May 27, 2025)
10.205
Unsecured Promissory Note dated June 5, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 9, 2025)
10.206
Form of Unsecured Promissory Note dated June 20, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on June 25, 2025)
10.207
Form of Senior Note (June 2025) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 1, 2025)
10.208
Securities Purchase Agreement by and between Evofem Biosciences Inc. and Aditxt, Inc. dated June 26, 2025 (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 1, 2025)
10.209
Form of Senior Subordinated Convertible Note of Evofem Biosciences, Inc. (June 2025) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 1, 2025)
10.210
Form of Warrant of Evofem Biosciences, Inc. (June 2025) (incorporated by reference to the Registrant’s Current Report on Form 8-K filed on July 1, 2025)
10.211
Amendment No. 6 to Amended and Restated Merger Agreement
10.212
Officer Letter with Christopher . Porcelli dated September 30, 2025
23.1
Consent of dbb mckennon , independent registered public accounting firm
31.1
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2
Certification of Principal Financial and Accounting Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certification of the Principal Executive, Financial, and Accounting Officers under Section 906 of the Sarbanes-Oxley Act of 2002
97.1
Clawback Policy (incorporated by reference to the Registrant’s Annual Report on Form 10-K filed on April 16, 2024)
101.INS
Inline XBRL Instance Document.
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
82
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized on this 31 st day of March 2026.
Aditxt, Inc.
By:
/s/
Amro Albanna
Name:
Amro Albanna
Title:
Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL BY THESE PRESENTS,
that each person whose signature appears below constitutes and appoints Amro Albanna and Thomas J. Farley, and each of them, as his or
her true and lawful attorneys-in-fact and agents, each with the full power of substitution, for him or her and in his or her name, place,
or stead, in any and all capacities, to sign any and all amendments to this Report, and to file the same, with exhibits thereto and other
documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and
each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about
the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that
said attorneys-in-fact and agents, or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements
of the Securities Act of 1934, this annual report on Form 10-K has been signed below by the following persons on behalf of the registrant
and in the capacities and on the dates indicated.
Signature
Title
Date
/s/
Amro Albanna
Chief Executive Officer
March
31, 2026
Amro Albanna
(Principal Executive Officer)
/s/
Thomas J. Farley
Chief Financial Officer
March
31, 2026
Thomas J. Farley
(Principal Financial and Accounting Officer)
/s/
Brian Brady
Director
March
31, 2026
Brian Brady
/s/
Sylvia Hermina
Director
March
31, 2026
Sylvia Hermina
/s/
Charles Nelson
Director
March
31, 2026
Charles Nelson
/s/
Shahrokh Shabahang
Chief Innovation Officer
and Director
March
31, 2026
Shahrokh Shabahang
83
ADITXT, INC.
CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED
DECEMBER 31, 2025 AND 2024
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID# 3501 ) F-2
Consolidated Balance Sheets F-3
Consolidated Statements of Operations F-4
Consolidated Statements of Stockholders’ Equity F-5
Consolidated Statements of Cash Flows F-7
Consolidated Notes to Financial Statements F-8
F- 1
PART I - FINANCIAL INFORMATION
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Board of Directors and Stockholders of
Aditxt, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheets of Aditxt, Inc. and its subsidiaries (the “Company”) as of December 31, 2025 and 2024, the related consolidated
statements of operations, stockholders’ equity, and cash flows, for the years ended December 31, 2025 and 2024, and the related
notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly,
in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and
its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been
prepared assuming the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company’s
net losses and negative cash flow from operations, raise substantial doubt about its ability to continue as a going concern. Management’s
plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result
from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to
assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial
statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well
as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ dbbmckennon
We have served as the Company’s auditor since 2018.
San Diego, California
March 31, 2026
F- 2
Item 1. Financial Statements
ADITXT, INC.
CONSOLIDATED BALANCE SHEETS
December 31,
December 31,
2025
2024
ASSETS
CURRENT ASSETS:
Cash
$ 3,198,599
$ 833,031
Accounts receivable, net
-
43,435
Inventory
5,774
11,245
Prepaid expenses
617,362
3,379
Subscription receivable
-
1,108,751
TOTAL CURRENT ASSETS
3,821,735
1,999,841
Fixed assets, net
880,241
1,547,774
Intangible assets, net
2,778
6,111
Deposits
61,586
87,672
Right of use asset
1,204,526
1,225,781
Convertible notes receivable, at fair value
3,899,859
-
Investment in Evofem
6,646,056
27,277,211
TOTAL ASSETS
$ 16,516,781
$ 32,144,390
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$ 7,693,410
$ 13,212,239
Mandatorily Redeemable A-1 Preferred Stock ( 678 and 0 shares)
779,049
-
Mandatorily Redeemable C-1 Preferred Stock ( 896 and 1,178 shares)
1,030,667
1,354,774
Stock payable
-
2,250,000
Notes payable, related party
-
115,000
Notes payable, net of discount
1,855,445
5,537,860
Financing on fixed assets
-
147,823
Deferred rent
53,443
106,075
Operating lease liability, current
808,179
683,352
TOTAL CURRENT LIABILITIES
12,220,193
23,407,123
Operating lease liability, long term
342,904
436,354
Derivative liability
2
14,517
TOTAL LIABILITIES
12,563,099
23,857,994
COMMITMENTS AND CONTINGENCIES
-
-
MEZZANINE EQUITY
Series C-1 Convertible Preferred stock, $ 0.001 par value, 10,853 shares authorized, zero and 7,195 shares issued and outstanding, respectively
-
7,195,000
TOTAL MEZZANINE EQUITY
-
7,195,000
STOCKHOLDERS’ EQUITY
Preferred stock, $ 0.001 par value, 3,000,000 shares authorized, zero shares issued and outstanding, respectively
-
-
Series A-1 Convertible Preferred stock, $ 0.001 par value, 22,280 shares authorized, 20,864 and 22,071 shares issued and outstanding, respectively
21
22
Series B Preferred stock, $ 0.001 par value, 1 share authorized, zero and zero shares issued and outstanding, respectively
-
-
Series B-1 Convertible Preferred stock, $ 0.001 par value, 6,000 shares authorized, 2,689 and 2,689 shares issued and outstanding, respectively
3
3
Series B-2 Convertible Preferred stock, $ 0.001 par value, 2,625 shares authorized, 2,625 and 2,625 shares issued and outstanding, respectively
3
3
Series C Preferred stock, $ 0.001 par value, 1 share authorized, zero and zero shares issued and outstanding, respectively
-
-
Series D-1 Preferred stock, $ 0.001 par value, 4,186 shares authorized, zero and zero shares issued and outstanding, respectively
-
-
Common stock, $ 0.001 par value, 1,000,000,000 and 100,000,000 shares authorized, 411,500 and 194 shares issued and 411,499 and 193 shares outstanding, respectively
412
1
Treasury stock, 1 and 1 shares, respectively
( 201,605 )
( 201,605 )
Additional paid-in capital
214,365,470
169,970,721
Accumulated deficit
( 209,808,770 )
( 168,094,569 )
Accumulated other comprehensive income
1,254,170
-
TOTAL ADITXT, INC. STOCKHOLDERS’ EQUITY
5,609,704
1,674,576
NON-CONTROLLING INTEREST
( 1,656,022 )
( 583,180 )
TOTAL STOCKHOLDERS’ EQUITY
3,953,682
1,091,396
TOTAL LIABILITIES, MEZZANINE EQUITY, AND STOCKHOLDERS’ EQUITY
$ 16,516,781
$ 32,144,390
See accompanying notes to the consolidated financial
statements.
F- 3
ADITXT, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Year
Ended
Year
Ended
December 31,
2025
December 31,
2024
REVENUE
Sales
$ 3,195
$ 133,985
Cost of goods sold
2,927
627,474
Gross profit (loss)
268
( 493,489 )
OPERATING EXPENSES
General and administrative expenses $ 0 and $ 33,071 in stock-based compensation, respectively
15,974,863
16,286,216
Research and development $ 10,000 and $ 6,712,663 in stock-based compensation, respectively
3,194,133
10,886,130
Sales and marketing $ 473,311 and $ 0 in stock-based compensation, respectively
401,996
197,863
Total operating expenses
19,570,992
27,370,209
NET LOSS FROM OPERATIONS
( 19,570,724 )
( 27,863,698 )
OTHER INCOME (EXPENSE)
Interest expense
( 681,156 )
( 4,188,725 )
Interest income
200,179
1,454
Amortization of debt discount
( 1,706,697 )
( 3,174,920 )
Gain (loss) on note exchange agreement
-
( 208,670 )
Change in fair value of derivative liability
14,515
414,501
Change in fair value of Evofem warrants
2,806,983
-
Impairment of Evofem F-1 Preferred Stock
( 23,766,209 )
-
Bargain purchase gain from purchase of Evofem convertible notes
328,071
-
Impairment of fixed assets
( 412,005 )
-
Total other expense
( 23,216,319 )
( 7,156,360 )
Net loss before income taxes
( 42,787,043 )
( 35,020,058 )
Income tax provision
-
-
NET LOSS
$ ( 42,787,043 )
$ ( 35,020,058 )
Deemed Dividends
( 1,387,250 )
( 5,907,011 )
NET LOSS ATTRIBUTABLE TO NON-CONTROLLING INTEREST
( 1,072,842 )
( 573,572 )
NET LOSS ATTRIBUTABLE TO ADITXT, INC. & SUBSIDIARIES
$ ( 43,101,451 )
$ ( 40,353,497 )
Net loss per share, basic and diluted
$ ( 1,153.83 )
$ ( 22,147,415.22 )
Weighted average number of shares outstanding during the period, basic and diluted
37,355
2
COMPREHENSIVE LOSS:
Net Loss
$ ( 42,787,043 )
$ ( 35,020,058 )
Other Comprehensive Loss:
Change in valuation of Evofem note
1,254,170
-
TOTAL COMPREHENSIVE LOSS
$ ( 41,532,873 )
$ ( 35,020,058 )
See accompanying notes to the consolidated financial
statements.
F- 4
ADITXT, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
YEAR ENDED DECEMBER 31, 2025 AND 2024
Preferred
A-1
Shares
Preferred
A-1
Shares
Par
Preferred
B-1
Shares
Preferred
B-1
Shares
Par
Preferred
B-2
Shares
Preferred
B-2
Shares
Par
Common
Shares
Outstanding
Common
Shares
Par
Treasury
Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income
Non-
Controlling
Interest
Total
Stockholders’
Equity
Preferred
C-1
Shares
Redeemable
Preferred
C-1
Total
Mezzanine
Equity
Balance December 31, 2024
22,071
$ 22
2,689
$ 3
2,625
$ 3
193
$ 1
$ ( 201,605 )
$ 169,970,721
$ ( 168,094,569 )
$
-
$ ( 583,180 )
$ 1,091,396
7,195
$ 7,195,000
$ 7,195,000
Issuance
of shares for registered direct offering, net of issuance costs
-
-
-
-
-
-
348,778
352
-
17,846,356
-
-
-
17,846,708
-
-
-
Issuance
of shares under ELOC, net of issuance costs
-
-
-
-
-
-
55,218
56
-
28,531,461
-
-
-
28,531,517
-
-
-
Redemption
of C-1 preferred stock
-
-
-
-
-
-
-
-
-
( 917,069 )
-
-
-
( 917,069 )
( 4,932 )
( 6,110,000 )
( 6,110,000 )
Reclass
of C-1 preferred stock to Mandatorily Redeemable Preferred Stock
-
-
-
-
-
-
-
-
-
( 163,440 )
-
-
-
( 163,440 )
( 2,263 )
( 1,085,000 )
( 1,085,000 )
Acquisition
of patent
-
-
-
-
-
-
-
-
-
10,000
-
-
-
10,000
-
-
-
Redemption
of A-1 preferred stock
( 529 )
-
-
-
-
-
-
-
-
( 308,000 )
-
-
-
( 308,000 )
-
-
-
Reclass
of A-1 preferred stock to Mandatorily Redeemable Preferred Stock
( 678 )
( 1 )
-
-
-
-
-
-
-
( 1,079,046 )
-
-
-
( 1,079,047 )
-
-
-
Warrants
issued for services
-
-
-
-
-
-
-
-
-
473,311
-
-
-
473,311
-
-
-
Rounding
from reverse stock split
-
-
-
-
-
-
7,310
3
-
1,176
-
-
-
1,179
-
-
-
Change
in valuation of Evofem note
-
-
-
-
-
-
-
-
-
-
-
1,254,170
-
1,254,170
-
-
-
Net
loss
-
-
-
-
-
-
-
-
-
-
( 41,714,201 )
-
( 1,072,842 )
( 42,787,043 )
-
-
-
Balance
December 31, 2025
20,864
$ 21
2,689
$ 3
2,625
$ 3
411,499
$ 412
$ ( 201,605 )
$ 214,365,470
$ ( 209,808,770 )
$
1,254,170
$ ( 1,656,022 )
$ 3,953,682
-
$ -
$ -
See accompanying notes to the consolidated
financial statements.
F- 5
ADITXT, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
YEAR ENDED DECEMBER 31, 2025 AND 2024
Preferred
A-1
Shares
Preferred
A-1
Shares
Par
Preferred
B-1
Shares
Preferred
B-1
Shares
Par
Preferred
B-2
Shares
Preferred
B-2
Shares
Par
Preferred
D-1
Shares
Preferred
D-1
Shares
Par
Common
Shares
Outstanding
Common
Shares
Par
Treasury
Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Non-
Controlling
Interest
Total
Stockholders’
Equity
Preferred
C-1
Shares
Redeemable
Preferred
C-1
Total
Mezzanine
Equity
Balance December 31, 2023
22,280
$ 22
-
$ -
2,625
$ 3
-
$ -
41
$ -
$ ( 201,605 )
$ 143,999,018
$ ( 127,741,072 )
$ ( 9,608 )
$ 16,046,758
-
$ -
$ -
Stock
option compensation
-
-
-
-
-
-
-
-
-
-
-
32,918
-
-
32,918
-
-
-
MDNA
asset purchase
-
-
-
-
-
-
-
-
1
-
-
1,008,668
-
-
1,008,668
-
-
-
Brain
asset purchase
-
-
6,000
6
-
-
-
-
-
-
-
5,970,437
-
-
5,970,443
-
-
-
Issuance
of shares for settlement
-
-
-
-
-
-
-
-
1
-
-
1,599,999
-
-
1,599,999
-
-
-
Restricted
stock unit compensation
-
-
-
-
-
-
-
-
1
-
-
153
-
-
153
-
-
-
Issuance
of shares for offering, net of issuance costs
-
-
-
-
-
-
4,186
4
-
-
-
( 532,164 )
-
-
( 532,160 )
4,186
4,186,000
4,186,000
Issuance
of shares for debt issuance costs
-
-
-
-
-
-
-
-
1
-
-
662,717
-
-
662,717
-
-
-
Modification
of warrants
-
-
-
-
-
-
-
-
-
-
-
4,137
( 4,137 )
-
-
-
-
-
Issuance
of shares for registered direct offering, net of issuance costs
-
-
-
-
-
-
-
-
36
-
-
3,022,939
-
-
3,022,939
-
-
-
Issuance
of shares under ELOC, net of issuance costs
-
-
-
-
-
-
-
-
105
1
-
12,739,556
-
-
12,739,557
-
-
-
Exchange
of warrants for Series C-1 Convertible Preferred Stock
-
-
-
-
-
-
-
-
-
-
-
( 6,000,006 )
-
-
( 6,000,006 )
6,000
6,000,000
6,000,000
Liquidation
damages
-
-
-
-
-
-
-
-
-
-
-
( 1 )
-
-
( 1 )
667
667,000
667,000
Conversion
of Series A-1 Convertible Preferred stock
( 209 )
-
-
-
-
-
-
-
1
-
-
( 1 )
-
-
( 1 )
-
-
-
Conversion
of Series B-1 Convertible Preferred stock
-
-
( 3,311 )
( 3 )
-
-
-
-
4
-
-
1
-
-
( 2 )
-
-
-
Exercise
of warrants
-
-
-
-
-
-
-
-
1
-
-
1,246,489
-
-
1,246,489
-
-
-
Issuance
of warrants as debt issuance costs
-
-
-
-
-
-
-
-
-
-
-
913,713
-
-
913,713
-
-
-
Modifications
of warrants as debt issuance costs
-
-
-
-
-
-
-
-
-
-
-
376,901
-
-
376,901
-
-
-
Modifications
of warrants
-
-
-
-
-
-
-
-
-
-
-
5,902,874
( 5,902,874 )
-
-
-
-
-
Derivative
liability from conversion feature on preferred stock
-
-
-
-
-
-
-
-
-
-
-
( 429,018 )
-
-
( 429,018 )
-
-
-
Rounding
from reverse stock split
-
-
-
-
-
-
-
-
1
-
-
21
-
-
21
-
-
-
Redemption
of C-1 preferred stock
-
-
-
-
-
-
-
-
-
-
-
( 548,602 )
-
-
( 548,602 )
( 3,658 )
( 3,658,000 )
( 3,658,000 )
Redemption
of D-1 preferred stock
-
-
-
-
-
-
( 4,186 )
( 4 )
-
-
-
( 28 )
-
-
( 32 )
-
-
-
Net
loss
-
-
-
-
-
-
-
-
-
-
-
-
( 34,446,486 )
( 573,572 )
( 35,020,058 )
-
-
-
Balance
December 31, 2024
22,071
$ 22
2,689
$ 3
2,625
$ 3
-
$ -
193
$ 1
$ ( 201,605 )
$ 169,970,721
$ ( 168,094,569 )
$ ( 583,180 )
$ 1,091,396
7,195
$ 7,195,000
$ 7,195,000
See accompanying notes to the consolidated financial
statements.
F- 6
ADITXT, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended
Year Ended
December 31,
2025
December 31,
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 42,787,043 )
$ ( 35,020,058 )
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation
473,311
33,071
Stock-based compensation from asset purchase
10,000
6,712,663
Depreciation expense
269,271
613,918
Amortization of intangible assets
3,333
3,333
Amortization of debt discount - note payable
1,706,697
3,174,920
Amortization of debt discount - note receivable
( 220,689 )
-
Loss on note exchange agreement
-
208,670
Modification of warrants for debt issuance costs
-
376,901
New principal from extension of notes, net of debt discount
-
451,974
Change in fair value of derivative liability
( 14,515 )
( 414,501 )
Change in fair value of Evofem warrants
( 2,806,983 )
-
Impairment of Evofem F-1 preferred stock
23,766,209
-
Disposal of fixed assets
-
3,000
Bargain purchase gain from purchase of Evofem convertible notes
( 328,071 )
-
Impairment of fixed assets
412,005
-
Changes in operating assets and liabilities:
Accounts receivable
43,435
364,891
Prepaid expenses
( 613,983 )
214,011
Deposits
26,086
18,738
Inventory
5,471
734,257
Accounts payable and accrued expenses
( 5,632,893 )
5,095,091
Settlement liability
-
667,000
Net cash used in operating activities
( 25,688,359 )
( 16,762,121 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of fixed assets
( 13,743 )
-
Investment in convertible notes receivable and warrants
( 2,425,000 )
-
Investment in Evofem F-1 preferred stock
-
( 5,000,000 )
Net cash used in investing activities
( 2,438,743 )
( 5,000,000 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from notes payable, related party
678,000
467,000
Proceeds from notes and convertible notes payable, net of offering costs
1,191,018
4,149,153
Repayments of note payable, related party
( 793,000 )
( 727,000 )
Repayments of note payable
( 6,613,882 )
( 5,287,942 )
Common stock, preferred stock, and warrants issued for cash, net of issuance costs
44,128,225
21,166,343
Cash from subscription receivable
1,108,751
4,335,877
Proceeds from exercises of warrants
-
1,246,490
Redemptions of A-1 preferred stock
( 308,000 )
-
Redemptions of C-1 preferred stock
( 8,898,442 )
( 2,851,839 )
Redemptions of D-1 preferred stock
-
( 32 )
Net cash provided by financing activities
30,492,670
22,498,050
NET INCREASE IN CASH
2,365,568
735,929
CASH AT BEGINNING OF PERIOD
833,031
97,102
CASH AT END OF PERIOD
$ 3,198,599
$ 833,031
Supplemental cash flow information:
Cash paid for income taxes
$ -
$ -
Cash paid for interest
$ 2,465,546
$ 1,235,640
NONCASH INVESTING AND FINANCING ACTIVITIES:
Issuance of shares for the conversion of notes payable
$ -
$ 500,000
Debt discount from shares issued as inducement for note payable
$ -
$ 1,576,431
Warrant modification
$ -
$ 5,907,011
Issuance of shares in asset purchase
$ -
$ 266,448
Shares issued for settlement
$ -
$ 1,600,000
Return of notes payable from Evofem merger agreement
$ -
$ 11,174,246
Accrued interest rolled into notes payable
$ 33,752
$ 538,223
Settlement of liability for Series C-1 Convertible Preferred Stock
$
$ 667,000
Subscription receivable
$ -
$ -
Exchange of warrants for Series C-1 convertible preferred stock
$ -
$ 6,000,000
Derivative liability from conversion feature on preferred stock
$ -
$ 429,018
ELOC payable
$ 328,071
$ -
Series C-1 redemption payable
$ 237,498
$ 1,354,774
ELOC commitment fee stock payable
$ 2,250,000
$ 2,250,000
Loan in escrow
$ 2,000,000
$ -
Reclassification of series A-1 preferred shares to liabilities
$ 517,444
$ -
Write off of financed asset
$ 147,823
$ -
Initial recognition of lease liability and right of use asset
$ 800,359
$ -
See accompanying notes to the consolidated financial
statements.
F- 7
ADITXT, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – ORGANIZATION AND NATURE OF BUSINESS
Company Background
Overview
Aditxt, Inc. ® is an
innovation platform dedicated to discovering, developing, and deploying promising innovations. Aditxt’s ecosystem of research institutions,
industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.”
The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address
significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice
is heard and valued, and empowers collective progress.
Reverse Stock Splits
On October 2, 2024, the Company effectuated a 1-for-40
reverse stock split (the “2024 Reverse Split”). The Company’s stock began trading on a split-adjusted basis effective
on the Nasdaq Stock Market on October 3, 2024. There was no change to the number of authorized shares of the Company’s common stock.
All share amounts referenced in this report are adjusted to reflect the 2024 Reverse Split.
On March 14, 2025, the Company effectuated a 1-for-250
reverse stock split (the “2025 Reverse Split”). The Company’s stock began trading on a split-adjusted basis effective
on the Nasdaq Stock Market on March 17, 2025. There was no change to the number of authorized shares of the Company’s common stock.
All share amounts referenced in this report are adjusted to reflect the 2025 Reverse Split.
On March 14, 2025, Pearsanta effectuated a 1-for-60
reverse stock split (the “2025 Pearsanta Reverse Split”). There was no change to the number of authorized shares of
Pearsanta’s common stock. All Pearsanta share amounts referenced in this report are adjusted to reflect the 2025 Pearsanta Reverse
Split.
On November 3, 2025, the Company effectuated
a 1-for-113 reverse stock split (the “November 2025 Reverse Split”). The Company’s stock began trading on
a split-adjusted basis effective on the Nasdaq Stock Market on November 3, 2025. There was no change to the number of authorized shares
of the Company’s common stock. All share amounts referenced in this report are adjusted to reflect the November 2025 Reverse Split.
On March 9, 2026, the Company effectuated a 1-for-8
reverse stock split (the “March 2026 Reverse Split”). The Company’s stock began trading on a split-adjusted basis
effective on the Nasdaq Stock Market on March 9, 2026. There was no change to the number of authorized shares of the Company’s
common stock. All share amounts referenced in this report are adjusted to reflect the March 2026 Reverse Split.
Reclassification of Previously Reported Preferred Stock Information
Certain prior period amounts have been reclassified
to conform to the current presentation related to the Company’s Preferred C-1 shares. As of December 31, 2024, the Company had
8,373 shares of Preferred C-1 outstanding, each with a stated value of $ 1,000 , for an aggregate stated value of $ 8,373,000 . These shares
were initially presented within mezzanine equity.
Subsequent analysis determined that the 1,178
of the Preferred C-1 shares which were mandatorily redeemable and classified as a liability should have reduced the mezzanine equity
from $ 8,373,000 to $ 7,195,000 .
After giving effect to the proper classification,
mezzanine equity should have reflected 7,195 shares of Preferred C-1 outstanding with an aggregate stated value of $ 7,195,000 , and additional
paid-in capital (“APIC”) should have increased by $ 1,178,109 to $ 169,970,721 .
As a result of this reclassification, total stockholders’
equity as of December 31, 2024, should have been $ 1,091,396 . The reclassification did not affect the Company’s net income, cash
flows, or total assets and liabilities for the period. Management has evaluated the impact of this reclassification and concluded that
it was not material to the consolidated financial statements.
F- 8
Risks and Uncertainties
The Company has a limited operating history and
is in the very early stages of generating revenue from intended operations. The Company’s business and operations are sensitive
to general business and economic conditions in the U.S. and worldwide along with local, state, and federal governmental policy decisions.
A host of factors beyond the Company’s control could cause fluctuations in these conditions. Adverse conditions may include: changes
in the biotechnology regulatory environment, technological advances that render our technologies obsolete, availability of resources
for clinical trials, acceptance of technologies into the medical community, and competition from larger, more well-funded companies.
These adverse conditions could affect the Company’s financial condition and the results of its operations.
NOTE 2 – GOING CONCERN ANALYSIS
Management Plans
The Company was incorporated on September 28,
2017 and has not generated significant revenues to date. During the year ended December 31, 2025, the Company had a net loss of $ 42,787,043
and negative cash flow from operating activities of $ 25,688,359 As of December 31, 2025, the Company’s cash balance was $ 3,198,599 .
As of December 31, 2025, the Company was not
subject to the offering limits in General Instruction I.B.6 of Form S-3 (the “Baby Shelf Limitation”). Thus, the maximum
amount of securities that the Company could offer and sell under its shelf registration statement on Form S-3 as of December 31, 2025
was
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